Ametris | Ametris Connect Platform | Booth 227 
https://ametris.com/ametris-connect  

Ametris Connect is a unified, device-inclusive digital trial software and data collection platform that helps sponsors deliver precision at every phase of clinical development. Built for modern, patient-centred and decentralized trials, it uses big data and AI to enable continuous, high-quality remote data capture, supported by Ametris’ operational, scientific, and regulatory expertise. Connect consolidates data from a broad suite of clinically validated devices and sensors, including ECG patch, pulse oximetry, spirometer, blood-pressure monitor, and actigraphy, to collect high-precision digital health data in real time. Its AI-powered risk monitoring and remote patient monitoring make trial design and execution more efficient, reducing costs and site burden while improving participant safety and experience. Algorithm-enabled metrics, real-time dashboards, and automated alerts support clinical decision-making at every phase of clinical development. Ametris Connect offers one of the industry’s most extensive collections of validated digital measures to enrich endpoints and address unmet measurement needs. Through the integrated Algorithm Marketplace, study teams can access a growing library of regulatory-ready, sensor-based digital measures, powered by licensed third-party algorithms, via a single, trusted workflow. Examples include continuous cough monitoring for respiratory research; validated abnormal movement measures (bradykinesia, dyskinesia, tremor) for Parkinson’s disease, Huntington’s disease, and essential tremor; digital mobility outcomes for COPD, PD, MS, and proximal femoral fracture; and continuous measures of nighttime scratching and sleep quality for atopic dermatitis and related conditions. Together, these capabilities provide a comprehensive digital health solution that improves data quality and delivers clearer insight into how treatments affect vital signs and behaviour. 

Auxilius | Auxilius | Booth 527 
http://www.auxilius.co 

The Problem: Clinical operations teams today rely on CROs and payment providers for visibility into their investigator grants, but these reports are cash-based and can lag by an average of 7 months, making it difficult to fully understand investigator grant obligations. Industry data shows that 44% of investigator costs aren't captured in vendor financial reporting because of this lag. This creates three challenges: (1) Sponsors can't accurately track what they're on the hook for for investigator grants until invoices finally arrive (2) They struggle to forecast funding needs and validate escrow needs (3) They have no independent way to confirm sites are being paid correctly and on time The Innovation: Auxilius uses sponsors' own clinical trial data to calculate investigator grant obligations in real-time. By ingesting data from EDC systems and mapping to CTAs and other budget documentation, we automatically calculate what sites are owed on protocol activities actually completed at the site, patient, and regional level. This creates a clear and up-to-date view of grant obligations that updates independently of CRO billing cycles. The Impact: (1) Budget Accuracy: Track actual obligations rather than waiting months for invoices, eliminating severe underreporting and budget surprises (2) Better Forecasts: More confidence in how much money will be needed for investigator grants (and how much to fund CRO/payments provider) (3) Payment Validation: Independently verify site payment accuracy and catch discrepancies before they damage site relationships 

BEKhealth | BEKplatform | Booth 1428 
https://www.bekhealth.com/platform/  

BEKplatform is an AI-powered patient matching and feasibility platform designed to improve trial feasibility, patient identification, and enrollment accuracy by transforming both structured and unstructured electronic medical record (EMR) data into actionable insights. In its latest release, BEKplatform achieves 96% accuracy in protocol matching, enabling research teams to apply increasingly complex inclusion and exclusion criteria with greater precision and consistency. The platform evaluates longitudinal patient records across diagnoses, medications, lab results, procedures, pathology, and free-text clinical notes—reducing reliance on manual chart review and minimizing protocol deviations that often originate at enrollment. A key advancement in this release is improved identification of edge cases and nuanced exclusion criteria that are frequently missed by rule-based systems or keyword searches. Using advanced natural language processing and large language models, BEKplatform interprets clinical context rather than isolated data points, supporting more reliable eligibility determinations earlier in the study lifecycle. BEKplatform integrates with approximately 85% of EMR systems on the market, and is used across more than 200 research sites spanning academic, community-based, and independent networks. The platform supports analysis across 30+ million patient records and 1000+ clinical trials, allowing sponsors to assess feasibility and enrollment potential using real-world, site-level data rather than theoretical projections. For sites, this release reduces screening burden and improves protocol adherence. For sponsors, it delivers higher-confidence feasibility, fewer screen failures, and stronger data integrity from first patient in. BEKplatform enables a shift from reactive trial execution to proactive, data-driven enrollment. 

Bioforum The Data Masters | BioGRID | Booth 533 
http://www.biogridsolutions.com  

BioGRID is an advanced, AI-augmented visual analytics platform that delivers end-to-end oversight and real-time data intelligence across risk management, audit trail review (ATR), and data integrity. By integrating diverse data sources—including EDC, eSource, and third-party vendor data—BioGRID creates a unified environment for proactive risk detection, regulatory compliance, and informed, data-driven decision-making. The platform directly supports modern quality frameworks as defined by ICH E6(R2/R3) and E8(R1) and is already in use across multiple live clinical studies. It acts as a unifying layer between functions—bridging gaps between data managers, medical monitors, project leads, and operational leadership—to facilitate seamless collaboration and elevate cross-functional visibility. In doing so, BioGRID supports the implementation of Risk-Based Quality Management (RBQM) frameworks at a time when data managers are increasingly central to clinical oversight and data-driven leadership. 

Biorce | Aika V1 | Booth 1201 
https://www.biorce.com/  

Aika is redefining how clinical trials are designed, justified, and executed. Aika is the first AI platform purpose-built for end-to-end clinical trial design and optimization. Unlike generic large language models trained on internet data, Aika leverages a multimodal AI architecture processing structured and unstructured data from approximately 1 million clinical trial protocols, regulatory submissions and outcomes databases across all major therapeutic areas. The platform transforms clinical development from a fragmented, manual process into an integrated, AI-augmented workflow. Research teams access evidence-based insights across protocol design, feasibility assessment, contract negotiation and budget estimation, while maintaining regulatory transparency. It is traceable to specific source protocols, enabling teams to defend decisions before discussing with regulators.. Technical specifications Architecture: Multimodal AI combining LLMs, NLP and Retrieval-Augmented Generation (RAG) Data foundation: ~1 million clinical trial protocols across all therapeutic areas Infrastructure: Google Cloud Platform with NVIDIA AI compute; GxP-compliant, SOC2 Type II certified Core capabilities: Protocol element extraction, comparative analysis, automated scoring systems, generative AI for protocol drafting, citation-level explainability What's new Aika is evolving beyond protocol design into full clinical execution, introducing AI-powered contract negotiation, CDISC- and USDM-compliant protocol digitalization, and automated budget estimation, turning weeks of manual work into hours. Upcoming releases expand Aika from protocol design into operational execution: Protocol generation & evaluation AI-powered contract negotiation Clinical protocol digitalization - USDM and CDISC-compliant Automated budget estimation These capabilities transform Aika from a design tool into a comprehensive platform supporting the entire clinical development lifecycle. Aika doesn’t just accelerate clinical trials. It makes better trials possible. 

BSI Life Sciences | BSI CTMS 25.2 | Booth 1314 
https://www.bsi-lifesciences.com/  

The BSI Life Sciences Clinical Operations Suite: A Future-Ready eClinical Platform BSI Life Sciences offers a complete and easy-to-use modern CTMS with built-in eTMF functionality—built to streamline clinical trial operations and improve outcomes. Our unified, future-ready SaaS platform brings CTMS and eTMF together to simplify compliance, enhance collaboration, and accelerate your clinical trials. With the combined innovations of BSI CTMS / eTMF 25.1 and 25.2, feasibility and study oversight take center stage. The site feasibility module now supports multiple assessment types and workflows, giving sponsors and CROs a structured, data-driven foundation for faster and more confident site selection. These capabilities help teams evaluate feasibility consistently across studies while reducing manual effort. Key highlights include: • An extended feasibility assessment portal with broader assessment support • Dynamic monitoring questionnaires that reduce workload and improve data quality • A sponsor portal enabling secure, controlled access for sponsors • Expanded configurability across the clinical trial life cycle • Improved unblinding functionality with clear data visibility Looking ahead, our AI-powered BSI Companion is coming soon. The companion is focused on end-user support and will assist users with everything from daily tasks to forecasting and data analysis. Through continuous innovation and customer feedback, our Clinical Operations Suite delivers smarter feasibility, stronger oversight, and a future-ready foundation for clinical research. 

Castor | Castor Catalyst v1.0 | Booth 1612 
https://www.castoredc.com/catalyst-ai-rwe/  

Castor Catalyst v1.0 solves the industry's costliest bottleneck: manual data entry and Source Data Verification (SDV). Whether managing high-volume GLP-1 studies, medical device registries, or complex oncology chart reviews, Catalyst eliminates the manual burden of moving source data into an EDC, compressing workflows from weeks into minutes. Core Capabilities Automated Data Entry: Our production-grade AI "reads" and extracts data from unstructured narratives, EMR screenshots, complex lab forms, and handwritten paper PROs. Human-in-the-Loop Oversight: An intuitive interface provides a side-by-side comparison between the original source document and AI extraction, ensuring researchers maintain 100% control. Rapid Enrollment: Participants pull their own records via HIPAA-release, turning a 40-hour human task into a less than four-hour process. Validated Impact: Users see a 90% reduction in data extraction costs and data entry cuts from 30 minutes to 6 minutes per record. Technical Specifications & Compliance Built on Google Cloud Vertex AI, Catalyst uses a consensus based workflow that leverages medical reasoning models for explainable data transformation and mapping. The secure, event-driven architecture features native HL7 FHIR and C-DASH CDISC mapping. It is fully GxP, 21 CFR Part 11, and HIPAA-compliant with broad data residency support. A "Visual Audit Trail" ensures data traceability back to source for automated remote SDV workflows. Innovation Preview See our Innovation Theatre presentation to see v2.0, featuring our Site Coordinator and CRA Agents, autonomous assistants designed to further eliminate site burden and automate source data verification. 

Citeline | Citeline PatientMatch - version 1 | Booth 1206 
https://www.citeline.com/en/products-services/patient-engagement-and-recruitment/patientmatch  

Citeline PatientMatch combines comprehensive algorithms, based on a protocol’s inclusion/exclusion criteria, with Citeline’s deep data assets. These datasets include labs, biomarkers, structured/unstructured electronic medical records (EMR) and other longitudinal real-world-data (RWD) from top reference labs and 400-plus hospitals/health systems. Citeline then delivers timely alerts to investigators when patients matching the algorithm receive new test results that could make them eligible for a study. The HIPAA-compliant solution also pairs Citeline’s in-house clinical team — comprised of PhDs, MDs, MPHs and PharmDs who support the curation and algorithm building — with robust RWD resources for a complete view of patients’ complex medical histories that match comprehensive protocols and help sponsors expedite trial enrollment. With Citeline PatientMatch, investigators and site staff receive de-identified alerts about highly qualified, potentially eligible patients under their direct care, within their hospital system, or within a targeted geographic range — surfacing those hard-to-find patients who are most likely to enroll. How it works: Our algorithm, built to target focused patient populations, monitors data sources to detect all relevant activities. The algorithm finds matches based on protocol-aligned patient activity. Patients are de-duplicated and tokenized for longitudinal tracking. Next, an alert is shared with the principal investigator and/or study coordinator. These alerts are tracked within a live dashboard for centralized reporting (a new feature). Citeline PatientMatch provides sponsors and investigators with customized support to pinpoint eligible patients before a treatment plan is finalized. 

ClinAsyst | ClinAsyst Greenlight | Booth 1336 
https://clinasyst.com/  

ClinAsyst Greenlight is an intelligent study startup system designed to transform the most time-intensive and operationally complex phase of clinical research. Currently in active development with a targeted launch in Q1 2026, Greenlight represents a strategic expansion of the ClinAsyst product portfolio and a key milestone in the company’s evolution from traditional CTMS tools—often little more than glorified spreadsheets—into the world’s first Clinical Trial Success System (CTSS). Greenlight is engineered to enable research sites to reduce study startup timelines by up to 50% through intelligent automation, integrated data systems, and streamlined process optimization. By standardizing startup workflows, improving data connectivity, and increasing predictability across site activation activities, Greenlight directly addresses long-standing inefficiencies that delay trial initiation and drive unnecessary operational cost. A core design principle of ClinAsyst Greenlight is deployment flexibility. The platform is being built to function both as a standalone solution and as a fully integrated component of the broader ClinAsyst ecosystem. Research sites and sponsors will be able to adopt Greenlight independently, regardless of whether they use ClinAsyst’s CTMS, while unlocking deeper capabilities and expanded value when deployed alongside the full clinical trial management suite. This modular architecture ensures broad market applicability, lowers barriers to adoption, and allows organizations to modernize study startup operations without requiring a full platform transition. At the same time, Greenlight strengthens the overall ClinAsyst value proposition by providing a scalable pathway to operational transformation. By accelerating startup timelines and improving operational clarity, ClinAsyst Greenlight delivers meaningful value to sponsors, sites, and ultimately patients—supporting faster trial initiation, stronger execution, and earlier access to innovative therapies. 

Clinical ink | TrialLens 1.0 | Booth 229 
https://www.clinicalink.com/  

TrialLens is Clinical ink's new AI-powered analytics platform that unifies clinical, operational, and connected device data into a single interface with conversational AI capabilities. TrialLens introduces "conversational analytics" for clinical trials—users can ask questions in plain English and receive instant answers from their trial data without navigating multiple systems, exporting CSVs, or waiting weeks for custom dashboards. Key features include: - Unified Data Platform — Integrates connected device data (CGM, wearables), operational data (enrollment, scheduling, compliance), and business data (support tickets, site performance) into one view - AI-Powered Q&A — Natural language interface powered by Amazon Q lets users ask questions like "Which sites had the lowest compliance this month?" and receive immediate, contextualized answers - Smart Dashboards — Pre-built visualizations for patient monitoring, continuous glucose monitoring, and site performance - Secure by Design — Row-level security ensures the AI respects user permissions; blinded users cannot access restricted data even through natural language queries Technical Specifications: - Built on AWS cloud infrastructure through partnership with the AWS Generative AI Innovation Center and AWS preferred partners - Configurable data refresh rates - Enterprise-grade security with role-based access controls - Topic-based AI architecture with curated business context, synonyms, and domain-specific terminology TrialLens democratizes trial analytics—no specialized training required, just questions and answers. 

Clinilabs | Clinical InSite 2.0 | Booth 932 
https://clinilabs.com/  

Clinical InSite 2.0 is a secure, cloud-enabled clinical data management and collaboration platform owned and developed by Clinilabs to support multi-study data workflows across clinical research studies. The system centralizes data intake from clinical sites, devices, and third-party systems, leveraging automated validation checks at every stage of the data lifecycle, including data submission by sites, data acceptance and review by Project Management, data scoring and processing activities, and Data Management review when results are returned, to help ensure accuracy, completeness, and consistency. Built with configurable workflows, the platform supports site, sponsor, CRO, and internal team collaboration through controlled access, audit trails, and standardized status queues that guide users from data submission through review, scoring, quality control, data corrections, and reporting. Query Management and Help Desk functionality is integrated into the platform. The platform supports secure data transmission, integrates with operational and analytic environments, and maintains traceability across the full data lifecycle. Hosted on AWS infrastructure, Clinical InSite 2.0 provides the scalability, reliability, and performance required to support both individual studies and global programs. The system includes integrated query management and a Help Desk ticketing capability, facilitating structured communication, timely issue resolution, and accountability throughout the study lifecycle. Customizable dashboards and reporting provide oversight of study performance, pending actions, and data readiness, enabling transparency and informed decision-making. Clinical InSite 2.0 is designed with security, compliance, and reliability in mind, combining secure access controls, permissions management, and full audit capabilities to support regulatory requirements and industry standards. The platform helps teams work more efficiently while maintaining exceptional data quality. 

CluePoints | Intelligent Query Detection (IQD) | Booth 1107 
https://cluepoints.com/what-we-do/intelligent-query-detection-iqd/  

For Data Managers overwhelmed by the volume, speed, and complexity of modern trials, Intelligent Query Detection (IQD) automates discrepancy review and removes reliance on traditional listings. IQD goes beyond basic anomaly flagging by suggesting standardized query text, integrating with EDC and central monitoring systems, and continuously improving through adaptive learning. The result is continuous inspection readiness without periodic, manual data reviews. IQD applies an AI-driven approach to detect discrepancies in near real time, supporting continuous data cleaning and rolling data locks. It reduces the need for rule-based configuration by allowing users to define checks through flexible, natural language prompts. IQD supports cross-form and cross-domain review, unifying multiple data streams into a single, scalable workflow that evolves as studies progress. When discrepancies are identified, IQD generates suggested query text, removing the need for manual data point identification and query drafting. Data Managers remain in control: suggestions are reviewed and approved before being automatically pushed to the EDC system. In validated production use cases, IQD has demonstrated high levels of precision and recall, significantly reducing manual effort while maintaining data quality. Recent enhancements include expanded natural language scenario creation, enabling non-technical users to configure and adapt review logic without programming expertise. IQD also classifies discrepancies by criticality, allowing sites to respond more efficiently and enabling sponsors to focus attention on higher-risk data. By shifting the human role from detective work to informed decision-making, IQD helps organizations accelerate timelines, reduce operational costs, improve submission readiness, and free expert capacity across the clinical portfolio. 

ConcertAI | ACT (Accelerated Clinical Trials) | Booth 315 
https://www.concertai.com  

Accelerated Clinical Trials (ACT) is ConcertAI’s next generation agentic AI–driven automation platform for clinical development, built on the CARAai platform. ACT integrates generative AI, reasoning agents, and healthcare specific ontologies to automate and optimize the full clinical trial lifecycle—from early study design through database lock, monitoring, submission, and continuous improvement. The platform provides enterprise grade workflow acceleration with standardized, configurable modules that seamlessly connect to sponsors’ data ecosystems (EHR, RWD, CTMS, eTMF, EDC, document repositories, and external sources such as PubMed and CT.gov). It eliminates manual burden and reduces cycle times across clinical development and operations. Core capabilities include: *AI enabled workflow automation for clinical development, clinical operations, epidemiology, and medical affairs. *Low to no lift data integration across real world data, CTMS, EDC, eTMF, publication data sources, and enterprise systems. *Centralized integration architecture, connecting Medidata Rave, Oracle Clinical, Veeva Vault (CTMS/eTMF), Medidata Balance, ePRO/eCOA, SharePoint, and more. *Persona driven workflow assistants for study designers, feasibility analysts, operations leads, and monitors. ACT is being deployed within life sciences companies and CROs and leverages ConcertAI’s legacy of delivering award winning, AI-enabled trial capabilities and RWE products across the industry. 

CRIO | CRIO Central eSource | Booth 1601 
https://clinicalresearch.io/products/esource/central-esource/  

CRIO Central eSource: Centralized Templates, Local Flexibility CRIO introduces Central eSource - sponsor-provided, protocol-driven electronic source templates that standardize data capture across trial sites while preserving local flexibility. This new capability transforms the traditional site-built model where each site independently creates templates, requiring 35-40 hours per study and introducing cross-site inconsistency. Product Description Central eSource delivers pre-configured, protocol-aligned templates directly to sites, eliminating template build time from site activation. Sites can supplement these core templates with local templates to accommodate institution-specific workflows, procedures, and regulatory requirements - maintaining standardization where it matters while enabling customization where sites need it. Key Benefits: Accelerate activation - Remove 35-40 hours from site startup timelines Ensure consistency - Standardized core data structure across all sites Preserve autonomy - Sites supplement with local templates for unique procedures Embed quality - Protocol compliance checks and validation rules at the point of the patient encounter Enable remote monitoring - Real-time sponsor access with comprehensive audit trails Reduced transcription burden – Nearly eliminates duplicate entry, manual transcription effort, and associated errors Technical Specifications Cloud-based SaaS on Google Cloud Platform 21 CFR Part 11 compliant with ALCOA+ audit trails ICH E6(R3) and E8(R1) GCP alignment Native and third-party EDC integration with pre-mapped data flows Role-based access controls and electronic signatures API access for labs, randomization, and ancillary systems Enterprise security (ISO 27001, SOC 2 Type II via GCP) Mobile-responsive web interface.

Crucial Data Solutions | TrialKit; v8 | Booth 824 
https://crucialdatasolutions.com/  

TrialKit AI is a module within the unified TrialKit eClinical platform that uses advanced predictive modeling to simulate study conduct, generate realistic participant data, and validate study designs before research begins. This release introduces expanded multiyear simulation capabilities, study-specific virtual cohorts, and automated CRF population that maps directly to each protocol’s visit schedule. Traditionally, trial design and data generation require extensive human effort, from protocol interpretation to manual study build validation. TrialKit AI changes that by using a protocol-aware model trained to interpret the digital study configuration built within TrialKit. Once a study is configured, the AI can understand its endpoints, schedules, forms, and logic rules. It then generates synthetic participants who match the trial’s inclusion criteria and simulates outcomes over time. The latest release, version 8.0, enables large-scale, rapid simulations such as projecting a five-year chronic disease trial in minutes. Users can model thousands of virtual participants with diverse characteristics, apply different treatment arms, and visualize likely outcome trajectories or protocol risks. The resulting synthetic CRF data is written directly into the TrialKit database, allowing teams to evaluate protocol feasibility, refine visit schedules, test workflow assumptions, and identify operational bottlenecks early. This same synthetic dataset generation also accelerates study build validation. Instead of manually keying test data, TrialKit AI automatically populates forms based on expected clinical scenarios, significantly reducing one of the most time-consuming steps in study deployment. TrialKit AI is built on a proprietary, domain-trained model owned entirely by Crucial Data Solutions and integrated natively within the broader TrialKit platform. 

Curebase | Sitebase 1.0 | Booth 306 
https://www.curebase.ai/  

Curebase On-Device AI: Control Without Compromise Curebase is the first and only eClinical vendor with AI that runs entirely on-device. No cloud. No data leaving your environment. Just AI that works the way clinical trials actually require. That might sound like a small technical detail, but it changes everything. The default approach to AI today involves sending sensitive clinical data to third-party cloud models through external APIs. Or worse, uploading it straight into a web interface. It's fast. It's convenient. But it also means losing control over where your data goes, how long it's retained, and whether it ends up training someone else's model. For regulated clinical work, that's a real problem. Running AI locally flips that equation. Voice navigation, document transcription, and more can happen right on the device, with no data ever touching the cloud. No leakage. No surprises about retention policies. No dependency on external systems or changing terms of service. Until recently, this kind of capability wasn't practical for clinical research teams. The technology simply didn't exist in a form that worked for regulated environments. Now it does. And here's the other part: through Sitebase, Curebase is making modern eClinical technology available to research sites for free. Sites shouldn't have to choose between outdated systems and budget constraints. They deserve software that's actually built for how clinical research works today. Frontier models optimize for intelligence. We optimized for control. Because in clinical trials, control comes first. 

Delfa | Participant Relationship Management (PRM) | Booth 428 
https://www.delfa.ai/product  

Returning to SCOPE, where Delfa first launched last year with AI voice agents, Delfa now returns with the PRM, the first fully AI-native Patient Relationship Management system built specifically for clinical research sites. The PRM is a purpose-built recruitment CRM, designed from first principles for site operations and enrollment, not retrofitted from a CTMS. It replaces fragmented spreadsheets, call lists, and manual data entry with a unified system that automates participant outreach, follow-ups, updates, scheduling steps, and documentation, allowing sites to move from first contact to enrollment in days rather than months. What’s new in this release is the expansion from standalone AI agents into a complete PRM platform. AI voice and messaging agents now operate as part of a system of action and record, tightly integrated with recruitment analytics and automated workflows. Agents handle repetitive calls, reminders, and re-engagement at scale, while real-time dashboards surface engagement signals that help coordinators prioritize the right participants and focus on high-value screening and visit coordination. The PRM scales outreach without scaling headcount. Recruitment runs continuously, keeps leads warm, and routes qualified responders to staff for human follow-up, freeing recruiters to spend their time where it matters most. The PRM plugs into existing site infrastructure, including CRIO, Realtime, HubSpot, and Zoho, enabling rapid adoption without replacing core systems. Early adopters report 3–7x recruitment productivity, with one leading site network enrolled 50% of its target within a single week, saving approximately 20 hours per recruiter. PRM is here, giving sites back time, focus, and control over enrollment. 

eClinical Solutions | elluminate | Booth 307 
https://www.eclinicalsol.com/platform/  

The elluminate Clinical Data Cloud is the best-in-class tool allowing for the full planning and execution of Integrated Quality Risk Management (IQRM). In addition to existing Risk-Based Quality Management (RBQM) integrated within a holistic clinical data and analytics infrastructure, the latest elluminate updates connect the Risk Assessment & Categorization Tool (RACT) to the Integrated Data Review Plan (IDRP). With this connection, the elluminate platform provides full capabilities required for execution of end-to-end risk strategy, connecting prioritized risks with relevant cross-functional data review activities including data review, medical and safety monitoring across multiple tiers of data criticality. Not only does elluminate enable full compliance with new regulatory requirements described in ICH E6 (R3), it sets the strong foundation to conduct fully Integrated Quality Risk Management. 

Embleema | EMR Pre-Screening | Booth 1514 
https://www.embleema.com/  

Embleema PreScreener is an instant EMR-driven prescreening tool that uses real-world clinical records to clinically characterize patients and validate trial inclusion/exclusion criteria before site screening. Unlike proxy-based approaches that rely primarily on coded signals, PreScreener supports criteria-level matching using patient-authorized access to electronic medical records, including unstructured documentation where nuanced eligibility signals often reside (e.g., specialist narratives, diagnostic reports, and longitudinal history). PreScreener is designed to plug into sponsor and CRO workflows: patients consent to share records remotely, Embleema’s workflow validates eligibility against protocol criteria in real time, and sites receive evidence-backed candidates with supporting documentation—reducing avoidable screen failures and site burden while accelerating time-to-enroll. Technical specifications: instant patient-consented EMR retrieval/aggregation; support for structured and unstructured clinical documentation; criteria-level eligibility assessment; secure PHI handling with controlled access; sponsor/CRO/site workflow integration. Outputs can be delivered as a portal view and exported as PDF or Excel based on stakeholder preference. What’s new in this release: a clearer criteria-to-evidence “Eligibility Packet” that links key inclusion/exclusion criteria to the supporting EMR source (e.g., relevant note/report/date), making referrals faster to review and easier to operationalize across teams. Also new are improvements to unstructured-document handling for complex criteria and streamlined handoffs so sponsors/CROs can route pre-qualified candidates to sites with fewer manual steps. 

Empatica | EmbraceMini | Booth 1610 
https://www.empatica.com/embracemini  

Empatica’s EmbraceMini is the world’s smallest actigraphy wearable designed for clinical trials and clinical care, combining continuous data collection with practicality and power. As part of Empatica’s FDA-cleared Health Monitoring Platform, EmbraceMini provides a non-invasive yet robust way to continuously capture sleep and activity data in real-world settings. EmbraceMini was designed to address one of the biggest challenges in remote health monitoring: participant compliance. With more than 90% of clinical trials delayed due to enrollment or retention issues (NIH), EmbraceMini’s patient-centric design helps reduce burden. Lightweight, discreet, waterproof, and suitable for continuous day-and-night wear, it features a 14-day battery life and fully automatic data transfer, requiring no active engagement from patients. By minimizing disruption to daily life and sleep behavior, and with its recent FDA-clearance for sleep monitoring, EmbraceMini supports long-term use in longitudinal and decentralized studies, improving retention, data quality, and real-world usability. EmbraceMini is able to monitor over 200 digital measures, thanks to high-resolution sensors, including a 3-axis accelerometer, gyroscope, magnetometer, and ambient light sensor, enabling detailed assessment of activity, circadian rhythms, and sleep. Sensor data is wirelessly transmitted to the Empatica Health Monitoring Platform, where continuous analysis enables the extraction of precise, clinically meaningful digital biomarkers from patients. Crucially for sleep research, EmbraceMini’s small size and long battery life minimize patient burden, important given that obtrusive devices can negatively impact comfort, sleep, and data integrity. Its modular architecture allows flexible wear locations and compatibility with dedicated accessories, adapting seamlessly to diverse study designs and patient needs. 

EmVenio Clinical Research | Patient Navigator | Booth 1021 
https://www.emvenio.com/patient-navigator/  

EmVenio’s Patient Navigator is a personalized support service designed to remove the logistical and financial obstacles that often prevent patients from participating in clinical trials. The service provides coordinated travel, lodging, transportation, daily scheduling support, real-time communication, and a streamlined reimbursement process—ensuring patients have everything they need to fully engage in their study with confidence and clarity. Patient Navigator exists because clinical trial participation is frequently hindered by complex, time consuming, and costly logistics. Many patients must travel long distances, arrange caregiving support, take time away from work or family, or navigate unfamiliar cities just to complete required study visits. These challenges disproportionately affect rare disease, pediatric, geographically dispersed, and mobility or cognition challenged populations—leading to lower enrollment, reduced diversity, and higher dropout rates across trials. Sites and sponsors also face significant operational burdens coordinating patient visits, managing communication, and verifying and processing reimbursements, which strains resources and slows study timelines. By centralizing all patient-facing logistics through a single, compassionate support service, Patient Navigator helps reduce barriers that make study participation difficult. The result is improved access for patients who would otherwise be excluded, smoother operations for research partners, and stronger retention driven by a supportive, human-centered experience. 

Endpoint Clinical | Elosity | Booth 1013 
https://www.endpointclinical.com/solutions-elosity  

Elosity is Endpoint Clinical’s next-generation Randomization and Trial Supply Management (RTSM) solution, purpose-built to deliver unmatched flexibility, regulatory compliance, and operational efficiency for global clinical trials. Built on a modern, robust architecture, Elosity ensures seamless integration, pristine quality, and enterprise-grade security to support complex and adaptive study designs. Its intuitive, role-driven design empowers sponsors, CROs, and sites to operate with confidence while reducing operational complexity and delivering a best-in-class user experience. Technical Highlights: Scalable, cloud-native architecture supporting global, multi-region deployments. Fully validated in accordance with 21 CFR Part 11, EU Annex 11, and ICH guidelines. Advanced supply and inventory management with configurable workflows and cross-study data enablement. Embedded integration marketplace and comprehensive API framework enabling seamless third-party connectivity. AI-enabled dashboards, insights, and notifications embedded within a modern, responsive interface. The latest Elosity release introduces meaningful advancements across supply intelligence, data, and platform governance. Deepened supply chain capabilities—including centralized pharmacy management, advanced sourcing strategies, native drug pooling, and optimized supply algorithms—drive improved efficiency, reduced waste, and greater control across the trial supply lifecycle. Expanded reporting and AI-enabled workflows deliver real-time operational insights, support rapid study design decisions, and streamline day-to-day trial management through eloAI. Enhanced version control and automated requirements generation simplify amendment management, improve configuration traceability, and enable targeted user acceptance testing through built-in deployment controls. By uniting innovation, quality, and regulatory excellence, Elosity continues to redefine RTSM—setting a new benchmark for agility, reliability, and intelligence in clinical trial execution. 

Everyday Health Group, Pregnancy & Parenting | Patient Recruitment | Booth 612 
https://www.ehg-pp.com/  

Everyday Health Group Pregnancy & Parenting provides recruitment services for women’s health and pediatric clinical trials through our What to Expect and BabyCenter apps and websites. Our brands reach 36m+ monthly users worldwide and 9-in-10 first time expectant moms in the U.S. Our digital media solutions connect our clients directly with the right audiences. In addition, our latest solution is a patient referral platform that enables teams to track and update patients’ statuses in a secure environment and maximize enrollment. The platform can be customized to support both traditional site-based trials and decentralized studies. At SCOPE, we will present the findings from a new study revealing key behaviors and attitudes that signal a willingness to participate in clinical trials. By layering first-party data with these insights in a trusted context, we offer actionable strategies to help achieve recruitment goals efficiently. 

Faro | Faro Designer & AI Optimization | Booth 1111 
https://farohealth.com/  

Faro Designer is a digitally native study design and optimization environment that embeds real-time intelligence directly into how clinical trials are built. This release introduces Faro AI Optimization, an agentic capability that proactively identifies opportunities to reduce patient burden, site effort, cost, and operational complexity, before protocols are finalized. The latest release adds proactive AI-driven optimization recommendations, enabling study teams to bypass weeks of manual research and move immediately into high-value strategic decision-making. Faro now delivers therapeutic-area–appropriate, fully-referenced recommendations aligned to established industry frameworks, such as those used by Tufts CSDD and TransCelerate, ensuring both scientific rigor and operational relevance. Each recommendation is transparently sourced, allowing teams to act with confidence in minutes, not months. Technical Specifications (Summary) -Cloud-native study design and optimization platform -Agentic AI workflow, delivering proactive design optimization recommendations -Therapeutic-area–specific guidance aligned to Tufts CSDD and TransCelerate frameworks -Fully referenced, data-backed recommendations with transparent sourcing -Structured protocol design (schedule of activities, endpoints, eligibility criteria, procedures) -Real-time analytics on patient burden, site effort, cost, and schedule complexity -Benchmarking against historical and publicly available clinical studies -Embedded, real-time feedback within existing study design workflows -Rapid decision support—insights delivered in minutes, not weeks -Enterprise-grade security and governance -Scalable architecture supporting downstream automation 

Fortrea | Fortrea Intelligent Technology - Version 1 | Booth 1007 
https://www.fortrea.com/  

Fortrea Intelligent Technology can transform clinical trial operations by integrating AI-powered, persona-driven solutions that help automate workflows, streamline oversight, and elevate productivity—enabling sponsors, investigator sites and Fortrea project teams to deliver trials faster, with greater predictability, agility and quality. 

Genomenon | Literature-Derived Real-World Evidence for Pharma Decision-Making | Booth 435 
http://www.genomenon.com  

Genomenon’s Literature-Derived Real-World Evidence (LD-RWE) is a newly launched offering that converts unstructured biomedical literature into structured, patient- and cohort-level real-world evidence to support pharmaceutical research, development, and commercialization. LD-RWE captures clinically meaningful data including diseases, genotypes, phenotypes, interventions, outcomes, timelines, and demographic context from published case reports, case series, and observational studies, while preserving full provenance to the source literature. For any indication, LD-RWE assembles a normalized, analysis-ready collection of all reported patients described across the literature. By harmonizing heterogeneous clinical narratives into a unified patient dataset, the product enables disease understanding, patient landscape characterization, and evidence generation where traditional RWE sources such as EHRs or claims data are sparse. This directly supports clinical trial design and feasibility, regulatory strategy and label expansion, and hypothesis generation for drug repurposing. New in this release is the introduction of a scalable, disease-specific extraction and aggregation framework powered by large-language-model–based retrieval-augmented generation (LLM-RAG) with evidence grounding. This enables patient-level extraction across millions of publications while maintaining traceability to original text passages. Configurable disease schemas ensure consistent capture across studies, allowing all published patients for a disease to be analyzed as a single cohort. Outputs are delivered as structured datasets or knowledge-graph–ready formats for integration into analytics workflows. Genomenon has applied these methods across numerous rare and genetically defined diseases, including precision oncology, to support prevalence estimation, natural history reconstruction, and trial design through manual and consultative efforts. This release operationalizes that capability, delivering an automated, auditable LD-RWE solution for clinical research professionals. 

GlobalData | Competitive Intelligence Clinical Results Comparator v1 | Booth 611 
https://cisolution.globaldata.com/  

The Clinical Results Comparator is a new tool that helps clinical and competitive intelligence teams quickly answer one of the most critical questions in drug development: how does our asset really perform versus the competition? By enabling rapid comparison across key safety, efficacy, and timing endpoints, the solution turns complex clinical results into clear, decision-ready insight that directly supports feasibility assessment, trial design, and portfolio prioritization. Built on continuously monitored, human-curated clinical data from conferences, journals, press releases, and clinical trial registries, the product removes the manual effort traditionally required to assemble and interpret cross-trial evidence. Teams can move straight to understanding differentiation, risk, and opportunity. Intuitive Endpoint Analysis Efficacy and Safety Heatmaps provide an overview of Umbrella Endpoints to spot where assets stand out, or fall behind, in crowded therapeutic landscapes. Three Visualization Views Column Comparison – Side-by-side comparisons of clinical performance Ranked Bar Charts – Rapid identification of top performers Response Timelines – Insight into when treatment effects emerge and how they evolve These visualizations enable fast, cross-trial comparison of assets, within therapeutic classes and across different mechanisms of action. Key study design variables, such as dosing, duration, patient populations, and endpoint definitions, remain visible throughout the analysis, ensuring results are interpreted with appropriate clinical context. Custom filters and saved views allow teams to repeat complex analyses in seconds, reducing time spent. The result is a faster, clearer path from clinical data to strategic action. The Clinical Results Comparator helps teams move quickly from complex results to well-informed development decisions. 

IgniteData | Archer | Booth 318 
https://ignitedata.com/  

Over the past year, IgniteData strengthened its clinical trial data platform by expanding integrations across EHR and EDC systems, doubling down on its system-agnostic foundation and enabling broader, faster network participation. Key advancements include: 1. The automated transfer of adverse event data directly from EHRs into EDCs, moving safety-critical information in days rather than weeks and significantly reducing manual queries. 2. Early production use of large language models further extended the platform’s ability to handle select unstructured data, complementing existing structured data workflows without compromising quality and user experience. By standardizing data movement across more sites and systems, IgniteData helped sponsors decrease data latency, improve data quality, and reduce downstream SDV and monitoring. Together, these advances demonstrate how a strong, interoperable network can materially improve the speed and quality of clinical trial data. 

Image Analysis Group | DYNAMKIA v.7.2 | Booth 1526 https://www.ia-grp.com  

DYNAMIKA is our cloud native clinical trial imaging platform, built to centralize acquisition, anonymization, quality control, and blinded central review of MRI, CT, PET, ultrasound, and X ray data across global studies. By delivering AI enabled, quantitative imaging endpoints, seamless connectivity with eClinical systems, and proven compliance with 21 CFR Part 11 and ISO 13485, SOC 2 type 2, DYNAMIKA helps sponsors accelerate timelines and achieve regulator ready submissions in oncology, immunology, neurology, rheumatology, metabolic conditions, and rare diseases. 

IMO Health | IMO Health Point of Care Patient Identification (V2) | Booth 226 
https://www.imohealth.com/life-sciences-solutions/  

IMO Health Point-of-Care Patient Identification is an EHR-native solution designed to identify eligible clinical trial patients as care is documented, not months later through claims or retrospective data pulls. Used daily by 90% of U.S.-based providers and enabled across all major EHR systems, IMO Health’s technology operates directly within the provider workflow, supporting real-time patient identification, provider alerting and site feasibility at scale. What’s new in this release: This latest release introduces enhanced real-time trial eligibility logic powered by clinician-authored medical terminology, mapped across all major coding systems. These upgrades significantly improve specificity, achieve ~95% accuracy, and materially reducing false positives that commonly delay recruitment and distort feasibility assessments. The platform now supports more dynamic alignment between protocol criteria and live clinical documentation, enabling earlier, higher-confidence detection of patient signals during routine care. Technical specifications & capabilities include: Deployment across 130+ EHR environments; EHR-agnostic by design Real-time patient identification triggered during clinical documentation High-precision terminology that captures clinical nuance beyond diagnosis codes Scalable support for site feasibility, recruitment planning, and ongoing trial execution By shifting patient identification upstream into the point of care, IMO Health's Point of Care Patient Identification enables trial teams to reduce feasibility risk, accelerate recruitment timelines, and make more confident, data-driven decisions throughout the clinical trial lifecycle. 

Innovative Trials | Innovative Trials Academy (ITA): Innovate & Educate | Booth 820 
https://innovativetrials.com/patient-recruitment-experts/  

At Innovative Trials, we know the real barriers to clinical trial recruitment and retention aren’t just logistical – they’re human. Public misunderstanding and low health literacy leave too many people – parents, students, community leaders – seeing trials as mysterious or risky, not as a vital step toward better health or even a career path they’ve never considered. The Innovative Trials Academy (ITA): Innovate & Educate changes that conversation outside trial sites and clinics, meeting people where they live, learn, and gather – in classrooms, community centers, and local groups. Launched in November 2025, ITA delivers age-appropriate, genuinely engaging clinical research education that demystifies trials, builds confidence, and sparks interest in careers from research nurses to recruitment specialists. Picture 9th graders running their own “mock trial” to grasp randomisation and leaving inspired to join the field. Since launch, we’ve been developing three key enhancements to multiply ITA’s reach and impact: -Modular School Education Kit: A ready-to-teach pack – slides, activities, teacher notes – so any classroom can run ITA sessions independently. -Micro-Learning Video Library: Bite-sized videos for community groups to use on-demand, explaining trials in plain language anyone can share. -Engagement & Impact Dashboard (EID): Live, anonymised data showing who we reach, how their understanding grows, and what careers excite them most. These turn ITA into a practical, repeatable programme that builds long-term trust in clinical research and a future pipeline of talent. That’s what “Innovate & Educate” means to us – and it’s the story we’re proudly bringing to SCOPE 2026 

Keiji AI | TrialMind | Booth 125 
https://www.keiji.ai  

TrialMind by Keiji AI is a regulatory-grade AI agent platform designed to accelerate clinical research, with a core focus on real-world data analysis, biostatistics, and trial design. TrialMind enables clinical, biostatistics, and RWE teams to analyze complex real-world data using natural language. Users can ask questions about feasibility, populations, endpoints, and outcomes, and TrialMind generates executable R and Python code that runs directly within the customer’s secure environment. This allows teams to explore EHR, claims, registry, and linked datasets without manual scripting, dramatically reducing analysis time while preserving methodological rigor. For trial design, TrialMind supports protocol optimization by evaluating eligibility criteria against real-world populations, modeling recruitment feasibility, informing endpoint selection, and simulating design tradeoffs before trials begin. Integrated predictive models enable outcome forecasting and scenario analysis, helping teams de-risk studies earlier in development. TrialMind also functions as a biostatistics copilot, supporting statistical modeling, programming, and validation workflows. It accelerates exploratory analyses, supports CDISC-aligned data structures, and assists with reproducible, auditable analysis pipelines suitable for regulated environments. Underpinning these capabilities is a large, curated clinical trial knowledge base, including hundreds of thousands of trial protocols and over a million biomedical publications. TrialMind’s literature review and evidence synthesis capabilities provide rapid context, benchmarking, and validation to support design and analysis decisions. Built with regulatory-grade security, TrialMind preserves data sovereignty through a secure, decoupled architecture—raw clinical and genomic data never leave customer infrastructure. Deployed by leading biopharma companies and academic medical centers, TrialMind helps teams design better trials, analyze data faster, and make confident, evidence-driven decisions. 

Kivo | Kivo | Booth 326 
http://www.kivo.io  

Kivo's cloud-based eTMF, RIM, and QMS platform offers a modern solution to clinical trial document management with unparalleled customer support. In 2025, we achieved >99.99% uptime - inclusive of scheduled maintenance windows, and maintained a 7 minute average response time for support inquires, averaging 2.1 hours to resolution. We are part-11 compliant, SOC2 and ISO 9001 certified, and fully validated. 

Maxis AI | Maxis AI 1.0 | Booth 920 
https://www.maxisit.com/  

AI Accelerated Study startup documents to IRB approval : autonomously orchestrated, fully auditable, and delivered in hours to days. Maxis AI’s Agentic AI platform transforms Study Start-Up documentation through IRB Submission from the traditional fragmented, multi-week effort into a fast, coordinated, and inspection-ready workflow completed in days, not weeks. In benchmarked proof-of-concept deployments, the platform reduced overall cycle time by 60–70%, while cutting manual effort across clinical operations, regulatory, and data teams by 50%+. The solution is powered by a multi-agent architecture. A Supervisor Agent interprets study goals expressed natural language, breaks them into executable steps, and orchestrates specialized agents across protocol, ICF, SAP, DMP, Recruitment Plan, ePRO, document distribution, document review and update coordination, IRB submission, study preparation, participant engagement, and data integration. Each agent is trained on clinical research data and regulatory standards (ICH-GCP, 21 CFR Part 11) and is securely augmented in real time using client-specific protocols, SOPs, and templates via Retrieval-Augmented Generation (RAG). What’s new in this release is verifiable, deterministic agentic execution built specifically for regulated GxP environments. Every deliverable is reviewed and optimized for accuracy by built-in verification and evaluations to drive higher level of accuracy, completeness, quality, referenceability, and regulatory compliance. Outputs that fall short are regenerated before release resulting in near-zero rework and consistently submission-ready artifacts. All actions and decisions are captured in an immutable audit trail, simplifying inspections and reducing compliance risk. Built on a cloud-native, microservices-based platform, Maxis AI integrates seamlessly with EDC, CTMS, eTMF, and patient engagement systems. ROI summary: Organizations can achieve up to 2–3 x faster study start-up, 50%+ operational cost savings, and measurable reductions in compliance risk and rework, delivering tangible value within the first study cycle. 

Medable | Agent Studio | Booth 806 
https://www.medable.com/platform/agent-studio  

As trial complexity, volume, and cost rise, clinical development remains constrained by manual and fragmented workflows. Medable’s agent platform, Agent Studio, removes current bottlenecks by embedding agentic automation directly into regulated clinical work—where speed, accuracy, and oversight are essential. Built specifically for clinical development, Agent Studio connects to existing trial systems, works with data in place, and operates within GxP-aligned guardrails. Agents are designed with auditability, validated performance, and human-in-the-loop control and scales across study start-up, conduct, and oversight, supporting multiple use cases across the development lifecycle. On this foundation, Medable delivers purpose-fit agentic solutions that target the highest-burden workflows in clinical operations. The CRA Agent improves site oversight by unifying data from CTMS, EDC, and RBQM systems to surface site-level risk and prepare CRAs for visits and follow-up. Based on modeled and early validation data, it is expected to save up to 8 hours per CRA per week, expand coverage from ~5 sites to 50+ sites per CRA. The eTMF Agent addresses one of the largest hidden labor costs in clinical operations by automating document classification, metadata extraction, and filing. Based on modeled scenarios and industry benchmarks, it is expected to eliminate 50–90% of manual TMF effort. The PI Summary & Review Agent streamlines investigator oversight by synthesizing participant data, highlighting material changes, and supporting efficient, compliant PI review and sign-off. Together, Agent Studio and its agents are delivering measurable value—already reducing cycle build times from weeks to under a day—improving speed, cost, and scale across the clinical development lifecycle. 

Medidata | Medidata Protocol Optimization | Booth 801 
https://www.medidata.com/en/clinical-trial-products/medidata-ai/clinical-trial-analytics/  

Medidata’s innovative Protocol Optimization solution, built on insights drawn from tens of thousands of historical clinical trials and 8000+ active studies worldwide, transforms trial design and execution by leveraging AI-driven capabilities to analyze study design and quantify the impact of protocol design decisions on operational outcomes like enrollment, retention, and cost. This solution can assess the impact on patient burden, site performance, and costs well in advance of the First Patient In (FPI), giving research and operations teams critical foresight into potential challenges. The solution, launched in June 2025, begins with industry benchmarking, flagging commonly used procedures, synthesizing procedure frequency and calculating the corresponding protocol complexity upfront. AI models use historical clinical trial data to simulate design trade-offs. The Patient Burden Index (PBI) incorporates many objective and subjective measures of the patient experience including: pain, hospitalization risk, procedure duration, and anxiety, enabling decisions to reduce patient burden without compromising endpoints. Predictive modeling then shows how protocol design changes are expected to impact burden and costs. This structured approach to protocol analysis significantly improves the protocol design process, decreases costly amendments and informs enrollment planning, leading to smoother, lower-cost trials that are easier on patients and sites. 

ObjectiveHealth | ObjectiveView | Booth 1600 
http://objective.health  

ObjectiveView is ObjectiveHealth’s real time clinical trial transparency platform designed specifically for sponsors and CROs who need clear, immediate visibility into study performance. Built on the same data foundation that powers ObjectiveHealth’s AI enabled recruitment engine, ObjectiveView provides a unified, intuitive dashboard that tracks screening, enrollment, site performance, and operational risk indicators with precision and speed. At its core, ObjectiveView delivers recruitment insight, offering sponsors a full view of the patient recruitment funnel—from prescreening activity through patient enrollment—updated continuously from integrated EHR signals and site workflows. This real time visibility enables study teams to identify bottlenecks early, forecast enrollment trajectories more accurately, and intervene proactively before timelines slip. The platform includes study performance monitoring, which surfaces operational metrics such as screen fail trends, enrollment velocity, visit completion, and retention indicators. Sponsors can quickly compare performance across sites, regions, or therapeutic areas, and use intelligent alerts to identify where support or corrective action is needed. ObjectiveView also supports personalized analytics, allowing users to create customized dashboards, exportable reports, and automated distributions for governance meetings or cross functional reviews. These capabilities enable teams to work from a single source of truth, enhancing collaboration between sponsors, CROs, and investigative sites. By combining transparent data flows with actionable insights, ObjectiveView helps accelerate decision making, reduce operational risk, and improve predictability across complex clinical trials. Sponsors gain a clearer understanding of site behavior, patient dynamics, and study health—empowering them to deliver trials more efficiently, with higher quality, and with less uncertainty. 

OncoLens | OncoLens Longitudinal Patient Analysis | Booth 1422 
https://www.oncolens.com/  

OncoLens has introduced AI-driven longitudinal patient analysis to transform its 220+ community cancer centers into a trial-ready network. Unlike static feasibility tools or episodic recruitment platforms, OncoLens embeds into daily cancer care operations—analyzing real-time clinical workflows to detect trial-relevant signals as they emerge. Our technology innovation continuously monitors patient journeys across biomarker testing, treatment transitions, disease progression, and eligibility milestones. Machine learning algorithms flag trial-ready patients weeks before traditional chart review methods. OncoLens now accesses and analyzes hidden next-generation sequencing (NGS) reports combined with longitudinal clinical context, unlocking hard-to-find biomarker data that typically remains buried in unstructured documents. Clinical intelligence is now embedded into the community infrastructure where cancer care already happens. Surfacing therapy and trial-relevant signals with integrated NGS insights in real-time—disease progression, biomarker gaps, treatment transitions, and eligibility milestones—enables earlier identification and more accurate pre-screening without site effort at scale. Multi-Stakeholder Impact: - Sponsors: Evidence-based feasibility, reduced screen failures, and access to biomarker-rich patient populations previously hidden in community settings allows teams to prioritize higher yield sites, refine enrollment assumptions, and avoid low value outreach. The result is faster startup and site activation, steadier enrollment velocity, and stronger alignment between protocol design and real world execution. - Sites: Zero pre-screening burden—OncoLens handles patient identification, biomarker extraction, and eligibility matching within existing workflows. Sites convert from trial activation to first patient enrolled in weeks, not months. - Patients: Access to genomically-matched trials at their local community hospitals with established care teams. 

Orbis Clinical Life Sciences Solutions | GxP Audit Solutions | Booth 1508 
https://orbisclinical.com/gxp-auditing/  

Simplify Compliance with Orbis Clinical's GxP Auditing Solutions Ensuring your pharmaceutical operations run seamlessly starts with robust compliance—and Orbis Clinical is here to help. Our GxP (Good Practice) auditing services are thorough, insightful, and designed to simplify complex regulatory requirements. From manufacturing to clinical trials and laboratory operations, we transform audits into opportunities for improvement, making the process seamless and impactful. The Orbis Clinical Advantage Enjoy the Journey: At Orbis, we believe compliance should be collaborative and empowering. We engage with your team to ensure you’re not just meeting standards but thriving. Stress-Free Audits: Our friendly, streamlined approach removes the anxiety from audits, delivering clear, actionable insights without the stress. Beyond Compliance: We don’t just help you pass audits—we enhance your operations, optimize processes, and make compliance second nature. Expert Team with a Personal Touch: Partner with passionate professionals who combine industry expertise with a commitment to making every step of the process seamless and engaging. 

Paradigm Health | Paradigm Health | Booth 118 
http://www.paradigmhealth.ai  

Paradigm Health announced that they have acquired Flatiron Health's Clinical Research Business. The transaction includes the industry’s most extensive tech-enabled U.S. oncology research network and Flatiron’s suite of clinical research solutions, and establishes a multi-year collaboration between the two organizations to maximize the benefits for providers, sponsors, and patients. The result of this is an immediately expanded network that include more than 25 academic medical centers and health systems, as well as access to nearly 100 community oncology practices nationwide, reaching over 2.4 million patients across the United States. Paradigm Health now can now provide access to clinical trials as a care option to patients in 45 U.S. states as well as Israel and Japan. 

PhaseV Trials Inc. | ClinOps Optimizer | Booth 1424 
https://www.phasevtrials.com/solutions/clinical-operations  

ClinOps Optimizer redefines how clinical trials are executed. It puts sponsors back in the driver’s seat. ClinOps Optimizer replaces static, relationship-driven site lists and opaque CRO reporting with real-time, AI and ML powered decision control. It identifies the sites that actually move trials forward by aligning real-world patient availability with protocol I/E criteria, operational metrics, recruitment rate modeling, investigator experience, and execution signals. Instead of guessing or spreading resources thin, sponsors focus on the sites most likely to enroll, perform, and deliver, accelerating timelines and improving predictability from day one. In a Phase 3 oncology trial conducted with a top-five global pharma sponsor, ClinOps Optimizer eliminated focus on 33 low-value sites, contributing to an estimated nine-month reduction in overall study duration and ~$20M in overall savings. Beyond selection, ClinOps Optimizer deploys a real-time monitoring dashboard across the full site footprint, giving sponsors live visibility into enrollment, screen failures, dropouts, and site performance. Automated alerts enable immediate, data-driven course correction. This is the future of sponsor-led clinical execution - where decisions are continuously informed by real-world data, not locked in at trial start. 

Phastar | Clinical Intelligence (Data Analytics Platform) Platform | Booth 320 
https://phastar.com/solutions/digital-acceleration/  

The rapid accurate assessment of operational, clinical and safety data is vital for sponsors who want to optimize data analysis strategies, improve reaction time and reduce costs. However, many lack the in-house expertise or technology to do this. The Phastar Clinical Intelligence Platform is a robust suite of apps and tools with the capability to securely aggregate large volumes of disparate and diverse data, automate data management processes, and ensure access to real-time data for effective decision-making. It leverages data visualization and analytics to provide near real-time data access, automating data processes and ensuring compliance while also offering user-friendly tools to aid understanding and rapid anomaly resolution. Clinical Intelligence offers a modular approach giving clients the flexibility to select the apps that suit their specific needs and budget, or to acquire the full suite to fully optimize processes. Whether clients require tools for advanced visualization, analytics, data management, DMC or more, they can adapt the platform to meet their requirements. A recent addition is the ability to access an interactive demo for the Medical Monitoring App (https://info.phastar.com/explore-our-clinical-intelligence-demo-for-medical-monitoring). This comprehensive solution brings together medical monitoring, safety reviews, and patient profiles into one secure, customizable environment. It helps sponsors visualize trends, streamline reviews, and make faster, more informed decisions across every stage of a trial. This complements other recent additions to the platform, including the launch of RBQM and Recruitment Forecasting apps (https://phastar.com/knowledge-centre/case-studies/patient-recruitment-forecasting/). Together, these applications allow sponsors to extract maximum value from their data while minimizing manual processes. 

Phesi Inc. | Trial Accelerator Platform V3 | Booth 514 
http://phesi.com  

Phesi, the leading patient-centric clinical data science company, has launched a new edition of its award winning AI-powered Trial Accelerator, offering a more integrated, contextualized patient-centric view to inform trial design, accelerate improved site-selection and predict performance. Now available as a single platform, Trial Accelerator provides a user-friendly, integrated global view of the patient by indication, biomarker, trial phase, country, and investigator site with instant AI-powered results. Trial Accelerator leverages contextualized data from 300m+ patients across 195 countries and 4,000+ indications from oncology to rare diseases. It delivers greater precision, insight and certainty across clinical development and faster cures to patients in need through core solutions including: • Digital Patient Profiles and Digital Twins • Protocol Design Optimization • Trial Feasibility • Country and Investigator Site Selection What’s new in the latest edition of Trial Accelerator: • A single integrated view of global data, delivered via one platform. • Contextualized real-world data from 300m+ patients (more than double since last year) • A unique extended catalog of 44 Digital Patient Profiles providing a detailed picture of the patient across disease areas including oncology, respiratory, metabolic, dermatology, inflammation, CVS, CNS and rare diseases. • User-friendly tooling enabling data to be analyzed with ease, empowering more objective decision-making for complex challenges. • Comprehensive performance scoring including an investigator’s potential to access the targeted patient population defined by the planned protocol and aligned to the Digital Patient Profile, quality of data, site activation and patient enrollment rate. Trial Accelerator has won innovation awards from Frost & Sullivan and Clinical Trials Arena. 

ProofPilot | Study CoPilot, Version 26 | Booth 1425 
https://www.proofpilot.com/  

ProofPilot’s purpose-built platform reduces operational complexity and drives meaningful engagement throughout the full trial lifecycle. In late 2025, ProofPilot expanded to support trial planning and site activation. New predictive analytics and a world class forecasting engine empower sponsors to proactively anticipate challenges. Planning > Activation > Enrollment > Engagement This evolution addresses gaps left by many clinical trial platforms: - True 360-degree visibility into patient and site engagement, supported by performance metrics that enable proactive intervention and continuous optimization - A white-labeled experience that preserves sponsor brand continuity and builds trust with sites and patients - A single, integrated platform to simplify study execution, eliminating the burden of managing disconnected technologies Technical specifications: Cloud-based SaaS Platform: Globally accessible solution with a fully responsive design across desktop, tablet, and mobile Enterprise-Grade Compliance & Security: HIPAA, GDPR, 21 CFR Part 11, SOC 2, and GxP compliant Open Platform for 3rd Party Integrations: Simplified integration with any platform or technology (eTMF, IRT, CTMS, SSO, etc.) ClinicalTrials.gov Integration: Automatic access to up-to-date study information Secure Real-Time Collaboration: Built-in chat between sponsors, CROs, and sites, with audit trails and export capabilities AI-Powered Study Assistant: Intelligent bot delivering fast, accurate study guidance Startup Progress Tracking: Clear visibility into startup milestones and task status Kanban-Style Recruitment Management: Visual workflows that streamline referrals, capture custom notes, and simplify pre-screening call scheduling Native Learning Management System (LMS): In-app training for sites with dynamic certificate generation, eTMF integration, and support for multiple course package types Cross-Channel Alerts: Real-time, customizable notifications via email, SMS, and in-app messaging.

Purity Health, LLC | Purity Information Exchange (PIE) 1.0 | Booth 934 
https://www.purity-health.com  

Purity Information Exchange (PIE) is a new multi-platform system designed to help clinical research teams collect quality health and research data across sites without the usual chaos. PIE gives research organizations a single platform to capture patient-reported outcomes, clinical observations, and research surveys, regardless of whether participants or researchers are located. It then analyzes that data to provide clear, usable insights. With PIE, a research team starts by setting up a project once, then uses the same system to invite and manage patients, capture responses, and monitor the data responses as the study runs. Questionnaires go directly to participants, data is collected securely whether it’s entered in a clinic or in the field, and results are immediately visible through live dashboards and reports. Instead of stitching together spreadsheets and systems, teams work from a single, auditable source of truth that keeps multi-site research organized. At its core, PIE enables organizations to collect and analyze clinical research data using the right level of structure and compliance for each use case. The platform includes configurable patient registries for observational research projects and clinical trials. PIE also provides expert biostatistics and data analysis. Robust integration and data services support secure ingestion and exchange of data from EHRs, labs and other third-party systems. PIE scales with your research, so you can focus on generating evidence, not managing infrastructure. Use PIE whether you’re running a small-scale research project or a large-scale study. 

QuantifiCare | QuantifiCare | Booth 732 
https://www.quantificare.com/  

QuantifiCare is transforming dermatology clinical trials with the first platform combining imaging and artificial intelligence for dermatology clinical trials. A global leader in imaging CRO services for Dermatology and Medical Aesthetics, QuantifiCare leverages 25 years of clinical trial expertise to deliver high-quality, standardized imaging solutions that strengthen clinical evidence and support regulatory success. Driven by advanced AI-powered technologies, QuantifiCare transforms clinical images into objective, reproducible, and actionable insights for dermatology clinical trials. By reducing variability, our solution enables faster, more confident decision-making throughout clinical development. QuantifiCare delivers an integrated imaging approach that spans image acquisition, centralized image management, expert clinical grading, and cutting-edge AI-driven analysis. This end-to-end solution ensures consistency and reliability across all phases of development, supporting high-quality clinical outcomes through standardized imaging and data interpretation. With a strong global presence across the Americas, Europe, and APAC, QuantifiCare supports worldwide studies with consistent standards and local execution. Trusted by leading pharmaceutical, biotech, and medical aesthetics companies, QuantifiCare is setting a new benchmark for innovation, reliability, and scientific excellence in dermatology imaging. 

RealTime eClinical Solutions | EDC Connect 4.25.0 | Booth 829 
https://realtime-eclinical.com  

EDC Connect is RealTime’s new interoperability capability that eliminates one of the most persistent sources of waste in clinical trials: duplicate data entry between eSource and EDC. For years, sites have asked the same question: “Does the data automatically move into the EDC?” And for most workflows, the answer has been no. In fact, according to the 2025 RealTime Reports: eSource ROI Survey Summary, 72% of respondent sites still manually transcribe eSource data into EDC and 68% report discrepancies caused by manual transcription. Many sites spend 10+ minutes per visit on duplicate entry, with many reporting 20+ minutes, adding up to 11+ hours per week for a coordinator managing just 10 patients weekly. EDC Connect enables teams to seamlessly map and export data from RealTime eSource into any CDISC ODM–compatible sponsor EDC, significantly saving time and reducing errors, without custom integrations. Technical Specifications: CDISC ODM export for EDC import Study-specific, field-level mapping between RealTime-eSource data elements and sponsor CRF/EDC structures Export checks for required fields, formats, and structure aligned to EDC import expectations Audit-ready workflow design within the RealTime platform (Part 11–aligned processes) Workflow: Capture → QC/Review → ODM export → EDC upload/import Launched Q4 2025, this release operationalizes eSource-to-EDC interoperability with a site-first workflow: map once, validate on export, QC upstream, and transfer clean data without re-entry. 

Revvity Signals | Revvity Signals Clinical Clinical Custom Listing Generator AI Assistant | Booth 126 
https://revvitysignals.com/products/clinical-development/signals-clinical  

The Clinical Custom Listing Generator within Revvity Signals Clinical is an AI-powered capability that enables clinical data managers, medical monitors, and trial teams to create precise, analytics-ready listings from clinical trial data using natural language requests, without the need for coding or programmer support. As part of the Revvity Signals Clinical SaaS platform, it centralizes clinical data and accelerates insights for data review, safety monitoring, and operational decision-making. (New launch) 

Science 37 | Direct-to-Patient Site | Booth 301 
https://www.science37.com/direct-to-patient-site/  

Science 37 Direct-to-Patient Clinical Trial Site Science 37 pioneered the first FDA-Inspected Direct-to-Patient Clinical Trial Site that enables study participation directly from the patient’s home. This approach represents a breakthrough in site operations: expanding reach, reducing participant burden, and improving data quality through a scalable, quality-driven model that is redefining how research is conducted. With 50-state medical licensure, Science 37 provides sponsors access to 100% of the U.S. patient population, far beyond the traditional 30-mile site radius. This nationwide reach enables broader inclusion, greater diversity, and faster enrollment—particularly for rare disease, rural, pediatric, and mobility-limited populations. Each study is supported by a dedicated and highly trained Science 37 team of board-certified, broadly-licensed investigators, research-grade nurses, clinical research coordinators, and site operations specialists—all Science 37 employees. This integrated staffing model ensures consistent quality, regulatory compliance, and an exceptional participant experience across every trial. Regulatory confidence is a key differentiator. Science 37 remains the first and only FDA-inspected direct-to-patient site, with inspections across five Phase 3 trials (including three pivotal studies) resulting in No Action Indicated (NAI) classifications, no Form 483s, and no objectionable conditions. To date, Science 37 has supported 185+ clinical trials and completed 13,000+ in-home visits, delivering 20–100% of total enrollment in pivotal and rare disease studies. In a pivotal rare disease trial, Science 37 was the top enrolling site, accounting for 55% of total participants with a 98% visit completion rate—while traditional sites averaged fewer than one enrolled patient. 

Scout | Data-Driven Automated Payments | Booth 1310 
https://39508480.fs1.hubspotusercontent-na1.net/hubfs/39508480/Videos/DataDrivenAutomatedPayments.mp4  

Automated payments done better. Scout doesn’t require rigid formatting or specific file set-up. Zero fees, zero penalties. Simply export data from any clinical data system and send to Scout. Scout makes payments automatically based on pre-set logic, freeing up invaluable time in everyone’s day. •Zero burden on participants, sites and sponsors •Reduce manual effort and error •Save time and cost •Monitor and query payments in real time Data-Driven Automated Payments: Financial transactions triggered by real-time data for efficiency and compliance. Significant Site Burden Reduction: Automates payments at no cost to sites, relieving personnel of the need to manage compliance and financial tracking tasks. Improved Compliance & Accuracy: Ensures timely and precise payments, reducing errors and enhancing reliability. Boosts Patient Experience: Streamlines stipend and reimbursement processes, improving patient satisfaction and retention. Comprehensive Implementation Support: We guide clients through setup, ensuring seamless integration and operation. Essential for Modern Trials: Awareness is vital for benefiting from increased efficiency and participant engagement. https://www.scoutclinical.com; https://39508480.fs1.hubspotusercontent-na1.net/hubfs/39508480/Videos/DataDrivenAutomatedPayments.mp4

SDC (Statistics & Data Corp) | SDC Insights 2.0 with SDC Sidekick AI | Booth 1327 
https://www.sdcclinical.com/the-sdc-ecosystem/sdc-insights-and-sidekick/  

SDC Insights 2.0 with SDC Sidekick AI is a next-gen centralized monitoring platform designed for proactive, AI-powered clinical trial oversight. It unifies data from EDC, CTMS, IRT, labs, wearables, and more—normalizing and integrating it automatically—providing real-time visibility across all data sources. At its core is SDC Sidekick, an explainable AI engine that offers predictive risk alerts, transparent query generation, and row-level traceability, ensuring audit-ready outputs and regulatory compliance (SOC 2, ISO, 21 CFR Part 11, ICH E6 (R3)). Key benefits include: • 23% fewer site visits through streamlined, risk-based monitoring • 14 days earlier detection of risk trends, identifying protocol deviations and safety outliers sooner • 60% of queries auto-identified by AI, saving CRAs approximately 4+ hours weekly • 100% mock-audit pass rate, with fully traceable AI decisions and no FDA 483s in pilot studies Deployable in under 30 days with no changes to existing infrastructure, SDC Insights 2.0 supports role-based dashboards tailored to CRAs, safety monitors, biostats, and clinical ops. It empowers teams—from clinical operations to medical monitoring—to prioritize actions, monitor performance, and ensure risk mitigation across global trials. SDC Sidekick elevates oversight by delivering confidence, efficiency, and compliance—empowering better clinical decisions every day. 

Strategikon Pharma | Maestro AI-Release 5.0 | Booth 1213 
https://clinicalmaestro.com  

Clinical outsourcing is challenging because of the inherent manner of execution. Brilliant teams spend their time reconciling budget spreadsheets, chasing document versions, and rebuilding context instead of applying their expertise. That's not complexity, that's friction that never should have existed. What’s new Maestro AI introduces an enterprise-grade AI assistant purpose-built for vendor management and outsourcing operations. This latest release significantly expands AI capabilities, now providing cross-module intelligence by connecting structured sourcing data in sourcing with operational and governance data in performance management. Impact During critical moments, such as sourcing due diligence, vendor selection, governance reviews, or ongoing performance oversight, teams often struggle to access the full picture needed to make informed decisions. Key information is fragmented across proposals, surveys, contracts, meeting documents, and historical performance records. As a result, teams spend valuable time searching for information context instead of evaluating risk, trade-offs, and strategy. Maestro AI brings this context directly into the decision workflow. During sourcing due diligence and vendor reviews, users can query vendor information, performance history, evaluations, audits, proposals, agreements, and governance documentation from a single interface. Maestro AI transforms static documentation into active insight: surfacing risks and generating decision-ready materials with full traceability, at the moment they're needed. The result: oversight shifts from reactive to proactive. Teams move faster and with confidence. Looking forward We believe the future of clinical outsourcing isn't fully automated or fully manual. Instead, it’s a balanced symbiosis between systems and humans - one that allows teams to finally operate at the level their expertise deserves. 

SunshineMD | SunshineMD Investigator Platform Version 4 | Booth 725 
http://www.sunshinemddata.com  

This new release focused on our The Sunshine Score: One Clear Signal of Clinical Trial Investigator Performance What the Sunshine Score Delivers: The Sunshine Score is a 1–100 percentile measure of an investigator’s real-world enrollment performance across industry- sponsored, U.S.-based trials. It distills years of activity into a number you can act on immediately. High score = consistently strong enrollment Low score = a higher risk of delays, non-enrolling sites and added cost Sponsors gravitate toward the score because it turns years of messy, inconsistent data into a clear, comparable performance indicator. A simple, powerful way to spot proven performers and avoid under-enrollers before a study begins. 

Suvoda | Suvoda App | Booth 1006 
https://www.suvoda.com/patient-app-for-clinical-trials  

The new Suvoda app reimagines how patients experience clinical trials—through a single, unified mobile interface that simplifies every interaction while maintaining the rigor sponsors and sites require. Knowing that patient dropout is a key risk to any clinical trial, our industry needs to do everything it can to support participants so they stay enrolled in their study. This solution is unlike any other app in the market today. It offers a unique combination of support tools that patients need—questionnaires, travel logistics, visit scheduling, and reimbursements—into one intuitive experience. This unified design minimizes patient confusion, reduces technical support needs, and strengthens data integrity across endpoints. With a simple, secure sign-in and a dashboard with assigned tasks, the app helps trials run smoother, smarter, and more patient-centric than ever before. Built with the power of the patented Suvoda Platform, the app allows patients to use their own devices, or provisioned ones if needed, to easily accomplish many of the tasks that are required of clinical trial patients: --complete questionnaires and diaries --schedule and reschedule study visits with real-time calendar availability --view travel details and itineraries --submit receipts and track reimbursement status --receive automated reminders that help trials stay on track At its core, the Suvoda app delivers a modern, consumer-grade experience tailored for clinical precision—bridging the gap between patient usability and enterprise-level reliability. Now, patients will know where to turn for the information, logistical support, and reminders they need to complete their trial. 

Teckro | Teckro LAUNCH2025.5 | Booth 826 
http://teckro.com  

Teckro introduced Patient Data Return in our platform to support our customers to be able to return individual data records to clinical trial participants quickly, securely, compliantly and at scale. 

Todata Analytics | SiteGrades (1.0) | Booth 1333 
https://todata.com/sitegrades/  

SiteGrades by Todata Analytics: Clinical research sites generate massive amounts of data across CTMS platforms, financial systems, and operational tools. But that data rarely connects in ways that are meaningful. Site leaders end up exporting spreadsheets, manually reconciling numbers, and making capacity decisions based on gut feelings rather than evidence. Built by site owners for site owners, SiteGrades connects data from existing systems — Advarra, Clinical Conductor, Devana, ADP, and dozens more — into a single, real-time dashboard. No migration. No workflow disruption. No per-user licenses. The platform grades site and network performance across six core metrics: Gross profit. Revenue. Average paced ratio. Database and recruitment. Enrollment vs. contracted. Studies per coordinator. Leaders can weight each KPI to reflect their organization's priorities and see performance dynamically update. SiteGrades provides: - Instant visibility into enrollment progress across all sites and studies - Capacity planning that maps high-volume visits to available resources - Profitability analysis by site, region, therapeutic area, or employee - Early identification of resource constraints before they impact trials Sites worldwide are now using SiteGrades for capacity planning across their network, and to see real-time enrollment progress. SiteGrades operates within Todata's SOC 2 and HIPAA-compliant framework. Data connections are read-only — nothing gets overwritten or altered. For sites and networks, SiteGrades delivers decision-ready intelligence in seconds. More at todata.com/sitegrades 

Trialbee | Trialbee Honey | AI-Powered Intelligent Recruitment | Booth 706 
https://www.trialbee.com 

Trialbee is the first global patient recruitment company to layer AI tools across its end-to-end platform, enabling a new era of Intelligent Recruitment. Embedded throughout the Honey Platform, these AI capabilities tackle the industry’s most persistent challenges—slow enrollment, fragmented data, overburdened sites, and limited real-time visibility for study teams. Rather than experimental AI, Honey delivers practical, production-ready intelligence that improves decision-making, reduces manual effort, and gives study teams earlier, clearer insight into recruitment performance—so risks can be identified and addressed before they impact timelines. Key AI features and smart tools—and the value they unlock—include: * AI-Generated Candidate Summaries Convert complex assessments, nurse notes, and activity logs into a single, actionable snapshot—enabling sites to move faster while giving study teams clearer visibility into candidate readiness and site progress. * Duplicate Patient and Spam Detection Protects data quality at scale by removing noise early, ensuring study teams can trust recruitment metrics and forecasts while reducing unnecessary site workload. * Automatic Masking of Potential PII Strengthens privacy and compliance across global studies by safeguarding free-text data without disrupting site workflows or slowing enrollment. * Scout - Intelligent AI Chatbot Empowers Trialbee teams to analyze massive volumes of recruitment data to unlock actionable insights, identify emerging risks sooner, and optimize strategies across complex, multi-site trials—translating into stronger execution and more proactive study team support. * Patient Access Optimization Flags potential mismatches such as preferred language or contact time zones, improving site–patient connections and increasing the likelihood that qualified candidates move forward. Together, these capabilities transform Honey into a true single source of truth for recruitment—where study teams gain earlier insight, sites spend less time on administration, and trials move forward with greater speed and confidence. By embedding AI across the recruitment lifecycle, Trialbee Honey sets a new standard for intelligent, scalable, and outcome-driven patient recruitment. 

TrialScreen | TrialScreen REFER (US) | Booth 1432 
https://trialscreen.org/  

TrialScreen REFER enables patient recruitment to begin immediately, without creative development, ethics delays, or upfront costs. Recruitment campaigns often require months of creative build, ethics review, and spend before the first patient is enrolled. REFER takes a different approach by focusing on education-first discovery and infrastructure, not advertising assets. REFER launches multi-channel digital outreach (Search, Meta, YouTube, TikTok) using therapeutic-level messaging that directs people to TrialScreen.org study listings. These listings qualify as directory information, removing the need for ethics review. Individuals can search all global studies, review plain-language details, and assess basic eligibility before choosing whether to share contact information. What makes REFER distinct is not just speed, but connectivity. TrialScreen actively corrects and maintains site contact information from public registries which is at best 20% correct due to missing or incorrect details (2026 Site Innovation Award Finalist for this activity). This means that qualified individuals can be routed directly to the research team, a step most recruitment solutions fail to address at scale. Why it matters *Fast: Campaign go live in days, no ethics required *High Quality: Informed, high-intent candidates *Self-service: Customer-defined spend caps and start/stop flexibility *Affordable: Pay-per-lead pricing with no upfront cost Technical capabilities *AI-driven ingestion of global trial registries with plain-language translation *HIPAA/GDPR-compliant encrypted lead delivery with automated follow-up *Real-time analytics across views, eligibility completion, pass/fail rates, and site selection REFER has supported trials in Australia since 2020 and is now available in the US, with reference customers prepared to share results. 

Trinetx | TriNetX LIVE - January 2026 | Booth 821 
https://trinetx.com/clinical-trial-design-optimization/  

TriNetX Enhanced API Capabilities with Conversational AI Integration - represent a major shift in how pharmaceutical companies access and utilize real-world data for clinical trial planning. The enhanced API allows partners to send study queries—using either medical codes or natural language—directly from their own systems to TriNetX's global network of 280+ million patients across 230+ healthcare organizations, receiving real-time patient counts, feasibility data, and site intelligence seamlessly integrated within current workflows. What's New: The innovation eliminates technical hurdles that have historically limited access to sophisticated RWD analytics. Researchers can now ask feasibility questions in plain language without requiring query-building expertise, broadening access to clinical research capabilities. By removing data silos, accelerating study planning, and supporting enterprise-wide digital initiatives, these capabilities are paving the way toward Agentic AI-level integration, bringing truly intelligent, autonomous data-driven decision-making closer to reality. The API is powered by TriNetX's proprietary clinical ontology, accessing data sourced directly from TriNetX's global provider network, ensuring insights are continuously refreshed and fully traceable. Technical Specifications: Real-time federated query execution across global healthcare network Create and edit queries from proprietary systems using medical codes or natural language Scheduled API runs for automated, regular data updates eliminating manual platform navigation Returns location-based patient counts at healthcare organization and site levels Provides comprehensive site intelligence including industry-standard identifiers and clinical trial experience Protocol optimization analytics for inclusion/exclusion criteria refinement.

UNIVO IRB | OneVerse (Version 3) | Booth 406 
https://www.univo-group.com/  

OneVerse is a modern, cloud-based IRB platform built from the ground up for the people who actually use it. Unlike systems adapted from general research or document tools, OneVerse is purpose-designed specifically for IRB work—removing friction, reducing repetition, and making daily tasks faster, clearer, and more intuitive. Every design decision starts with the user. The result is a sleek, simple interface that feels natural to navigate, even while managing complex submissions. Centralized tracking, role-specific views, and dynamically generated workflows guide users through each step based on the type of submission—so no one wastes time hunting for information or guessing what comes next. Intelligent data recall minimizes duplicate entry across documents and studies, freeing teams to focus on what matters most. Collaboration is seamless and transparent. Flexible user management allows teams of any size to work together in real time, with multiple contributors able to build submissions before they are finalized. Dashboards provide clear, actionable status updates, while live chat delivers fast, human support when it’s needed. For IRB users, OneVerse brings clarity and confidence to every determination. Submission history, built-in guidance, analytics, and dynamically generated review forms create a more efficient, context-driven review experience—supporting accuracy without added burden. 

Veeva Systems | Veeva OpenData Clinical | Booth 1106 
https://www.veeva.com/products/opendata-clinical/  

Veeva OpenData Clinical provides a verified global database of investigators and sites to streamline clinical trial management. The solution delivers a curated and comprehensive database with over 190,000 site and 230,000 investigator records across 70 countries to help biopharmas avoid costly trial delays caused by data inaccuracies and manual data verification. As part of the Veeva Clinical Platform, investigator and site data integrates with Veeva CTMS through automatic, daily updates to improve visibility and study team productivity. Veeva OpenData Clinical serves as a single source of truth, providing a complete view of investigators. This allows biopharmas to improve site relationships and reduce study timelines from startup through commercialization. Study teams can then shift focus from administrative cleanup to strategic activities, like data governance and inspection readiness. 

VivoSense | VivoSense Platform v2.2 | Booth 1236 
https://www.vivosense.com/  

The VivoSense Platform is an end to end, cloud based environment designed to manage, analyze, and operationalize digital health data from wearable sensors and connected technologies in clinical trials and healthcare. Built on VivoSense’s deep scientific and operational expertise, the platform centralizes study oversight, data quality assessment, advanced analytics, compliance tracking, and long term data stewardship. As part of VivoSense's Wearable Sensor CRO solution, the VivoSense data and clinical science teams fully manage, operate, and oversee the entire environment, providing hands on collaboration with pharma and CRO partners to ensure data quality, compliance, and study success. The platform supports diverse stakeholders: clinical operations, biostatistics, data management, regulatory affairs, and healthcare clinicians, by providing real time participant monitoring, automated task management, sensor inventory tracking, role based access controls, integrated reporting, and multi modal data visualization. Seamless interoperability with EDC, CTMS, cloud systems, and analytics tools ensures a streamlined flow of digital data throughout the full study lifecycle. 

WCG | ClinSphere Trial IntelX | Booth 901 
https://www.wcgclinical.com/technologies/trial-intelx/  

ClinSphere Trial IntelX – Predictive Intelligence for Clinical Trials ClinSphere Trial IntelX is redefining how sponsors and CROs plan and execute clinical trials. Built on a foundation of 80,000+ complete digitized protocols and 40,000+ operational benchmarked trials, Trial IntelX transforms trial design from reactive management to proactive foresight. By leveraging AI-driven predictive modeling, it empowers teams to anticipate enrollment timelines, mitigate operational risks, and optimize site and country selection — before the first participant is enrolled. What sets Trial IntelX apart is its ability to connect protocol design, operational performance, and real-world outcomes into actionable insights. Users can simulate multiple design scenarios, quantify participant and site burden, and benchmark across therapeutic areas — all within a secure, cloud-based environment integrated with WCG’s ClinSphere technology ecosystem. Features in this release: • Agentic AI delivers deeper predictive correlations for enrollment and performance forecasting. • Dynamic Ranking Engine provides real-time scoring of countries, sites, and investigators based on historical performance and competitive metrics. • Portfolio Optimization Module enables cross-study benchmarking for strategic investment decisions. • Streamlined Dashboards improve usability and accelerate scenario modeling. • Expanded Data Assets include 12,000+ site survey responses for richer operational intelligence. ClinSphere Trial IntelX is more than a tool — it’s a strategic partner for accelerating timelines, reducing costly amendments, and improving trial success rates. With predictive foresight at your fingertips, users can design smarter, start faster, and deliver better outcomes for patients worldwide. 

Yseop | Yseop | Booth 121 
https://yseop.com/  

Yseop is redefining regulatory writing to help life changing medicines reach patients faster. In the highly regulated pharmaceutical environment, Yseop transforms regulatory writing from a resource intensive manual process into an efficient one click experience. Our AI assistant supports the full lifecycle of regulatory document creation, from drafting and editing through finalization, across Clinical Study Reports, Patient Narratives, and CMC documentation including the Quality Overall Summary. Yseop delivers this capability at enterprise scale through software powered by a composite AI architecture that combines symbolic AI, machine learning, and large language models. This approach allows Yseop to automate the most complex regulatory content while maintaining transparency, compliance, security, and consistency required by global health authorities. For over a decade, Yseop has been a pioneer in regulatory writing automation, well before generative AI entered the mainstream. Today, the world’s leading pharmaceutical companies trust Yseop to accelerate document production without compromising quality or regulatory rigor. Our human centric AI platform continues to set the benchmark for responsible generative AI in regulated industries. This leadership was recently recognized by TIME Magazine, which named Yseop Copilot one of the Best Inventions of 2025 in the Medical and Healthcare category, highlighting our impact on AI driven automation and our mission to accelerate patient access to new therapies. What’s New Yseop’s latest release introduces a native integration with Microsoft Word, embedding AI powered automation directly into the primary authoring environment used by regulatory teams. This innovation eliminates context switching, accelerates user adoption, and enables a fully connected and compliant workflow from project kickoff through final submission, without disrupting established processes. This advancement represents a major step forward in making enterprise grade AI practical and scalable for regulatory teams. 

Zelta by Merative | Zelta, version 2025.6.0 | Booth 1321 
https://www.merative.com/zelta  

Introducing the groundbreaking 2025.6.0 release of Zelta, launched on October 10th—a leap forward that redefines industry excellence. Zelta provides a unified, cloud-based CDMS that fully complies with ODM standards. Users can customize modules and access them through a self-service platform, while also having support from a comprehensive service team—all you need is a web browser and internet access. Rather than being a simple upgrade, this transformation aims to redefine the industry standard. • Unmatched Speed and Intelligence in Study Build: Advanced, AI-powered study build tools accelerate workflows, empowering teams to accomplish more in less time. Proven results include:  40% faster creation of repeating forms and event cycles  32% faster to craft complex expressions with the enhanced logic editor  20% faster query creation with no coding required • Revolutionized Study Connect Experience: Featuring real-time edit checks and instant auto calculations, Zelta empowers study users with a modern, frictionless and intuitive interface. Key advantages include: • 91% of complex edit checks resolved in less than one day • 1.3% edit check fire rate, outperforming the industry benchmark of 2.6-3.1%—minimizing disruptions and maximizing quality. • 50% reduction in logic required for even the most complex phase II and III studies—making scalability simple and efficient. • Next-Level Reporting and Insight: Enjoy fully customizable reporting with personal filters, tailored views, and automated report sharing via email. Instantly access real-time data and navigate with a single click—empowering every user to move from data to decision faster than ever before. 

ZigZag QA | Site Quality Assessments | Booth 534 
https://www.zigzagqa.com/site-quality-assessments/  

Site Quality Assessments (SQA) is a risk-intelligence platform that standardizes how Sponsors and CROs assess, compare, and strengthen clinical site quality—before issues become deviations, data rework, or inspection observations. Where oversight is often episodic and subjective, SQA makes quality signals continuous, comparable, and action-oriented. SQA combines a targeted, role-based questionnaire with analytics that translate site inputs into a transparent Quality Scorecard and portfolio dashboard. Critical-to-quality domains include PI oversight, informed consent, safety reporting, investigational product accountability, source-to-EDC data flow, delegation/training, and computerized system controls. Responses are normalized on a 0–3 concern scale, weighted by CtQ importance, and surfaced as a Quality Tier with clear risk drivers and recommended actions. What’s new in this release: (1) reusable Sponsor and CRO templates with branching logic and “minimum-burden” question sets for consistent deployment across studies; (2) portfolio benchmarking with study/region/country heatmaps, trendlines, and automated re-tiering as signals change; and (3) an inspection-ready Evidence Pack that compiles scoring rationale, supporting responses, and tracked actions into an audit-traceable export. Technical specifications: secure web forms; SaaS (shared or private tenant) or managed deployment; configurable scoring, weights, thresholds, and alerts; role-based access; SSO/SAML; immutable audit logs; encryption in transit and at rest; and optional CSV/REST API import/export to connect with CTMS/EDC/QMS. SQA reduces burden through focused oversight and replaces subjective judgment with measurable, defensible signals—helping teams focus monitoring, training, and audits where they will have the greatest impact.