35+ New Products Eligible for Inaugural SCOPE Best of Show Awards
By Clinical Research News Staff
January 31, 2023 | Clinical Research News and ClinEco are pleased to announce the finalists for the first SCOPE Best of Show Awards. More than 35 new products to be presented at the Summit for Clinical Ops Executives in February in Orlando, Fla. have been chosen as finalists in the inaugural awards program, recognizing the best new products enabling clinical trials and clinical research.
For a product to be considered for the SCOPE Best of Show award, it must have been newly released—or significantly improved—since February 2022. Exhibiting companies entered their products for consideration in advance of the event. The product descriptions below were submitted by the entering companies.
Winners will be chosen by the SCOPE community in live voting during the event. Voting codes will be available at finalists’ booths and throughout the event. Voting will open when the exhibit hall opens on Tuesday, Feb 7, at 9:35am and will close at noon on Wednesday, February 8.
Winners will be announced live at the event on the exhibit hall floor on Wednesday, February 8, at 1:20pm.
The Best of Show competition is sponsored by Clinical Research News and ClinEco, the global clinical trials ecosystem and marketplace. A company’s level of event sponsorship or engagement with either sponsoring organization will have no bearing on the Best of Show competition.
2023 SCOPE Best of Show Awards Finalists
New Product: 1nData
Patient enrollment is chaotic, fails more often than it succeeds, and hasn’t had much meaningful innovation in a decade. 1nData is built to benefit all recruitment stakeholders: the study teams, the sites, and the patient. Study teams often don’t know recruitment is in trouble until it’s truly on fire. 1nData provides comprehensive real-time data on overall enrollment pace, screen-fail rates and reasons, site performance, and more. Instead of just regurgitating information study teams already know, these insights allow strategic decisions about budget and resources to happen sooner. Sites are overworked and understaffed; calling a long list of “leads” who probably won’t pick up, and likely won’t qualify for the study anyways is demoralizing and a waste of time. 1nData allows sites to intuitively interact with leads via SMS before calling, provides a secondary screening message through chatbot automation, and has self-scheduling built in. Patients who add a site screening phone call to their personal calendar pick up more than 90% of the time, compared with 30% of patients who just get an unannounced call. Patents get to use a simple screening form and receive communication through their preferred pathway – be that text, phone call, or email. They can interact with a bot any time to get more information or get in touch with a team member. By consolidating patients and building a thoughtful flow more people who are interested get the opportunity to consider the study – instead of forgetting during the 1-week window while they wait for a return call.
New Product: Advarra Longboat Platform 2.17
Research sites and life sciences companies leveraging their own unique technologies has resulted in a fragmented ecosystem rife with redundant processes and siloed technology adoption. In July of 2022, Advarra Launched Cloud-Based Secure Document Exchange between Advarra’s Longboat Platform and Advarra’s eRegulatory Management System. The solution, driven and developed through collaboration with Advarra’s Site-Sponsor Consortium, provides end-to-end integration and automated, seamless exchange of research documents between sites, sponsors, and CROs. Secure Document Exchange allows sites and sponsors to build new efficiencies while using their own practice management systems for regulatory document management. Advarra’s approach creates the first step in eliminating burdensome manual processes for research sites, allowing sites to leverage their existing technologies while creating more efficient workflows for sponsors and CROs. All regulatory documents, originating with a sponsor or at a site, can be managed, signed, and securely exchanged to the correct parties for long-term storage into the sponsor’s Electronic Trial Master File (eTMF) and site’s Investigator Site File, without requiring either the sponsor or research site to leave their organization’s technology. Secure Document Exchange within the Longboat Platform enables study teams to:
Centrally manage documents and document metadata and enable communications within a centralized platform
Distribute all necessary documents and subsequent metadata to sites globally in a consistent and recorded manner
Request documents required from sites on a global, regional, or single-site basis
Track and monitor the status of documents and requests
Route all relevant documents to the appropriate eTMF throughout the course of a study
Company: Almac Group
New Product: OVERSIGHT Trial Data Integrity Monitoring System
The audit trail is an integral part of any e-clinical system, and should be utilized as a tool to drive data reviews . The OVERSIGHT solution within Almac’s IXRS® platform is a critical control point given that in many instances the IXRS acts as an eCRF given it is the first point of entry and as such the source of data that is ultimately pushed to other systems (EDC, eCOA, CTMS). Such, it can be used to investigate any potential discrepancies between systems or ongoing reconciliation activities during the trial. Audit trail reviews conducted by data managers, statisticians, safety staff, and other roles can help identify data inconsistencies, outliers, and protocol deviations; plus any errors in data collection and reporting at a site or across sites; and other data integrity issues. It is critical to be able to quickly see trends and issues, then drill down into the details to accurately analyze what the trends show and take necessary action.
Company: Anju Software
New Product: TA Scan 6 (now with integrated diversity data)
TA Scan is a cloud-based clinical and commercial business intelligence tool that aggregates and connects global clinical trial data, presentation data, publication data, and many other data sources from the public domain into a single intuitive database. Our data represents an accurate, comprehensive view of global R&D activity, allowing users to make more informed decisions around their study designs, feasibility, site identification, and diversity and KOL identification and management strategies.
The TA Scan solution provides a quick and easy way to identify and evaluate data at any desired level of detail: clinical trial data, site information, publications, expert profiles, geographical mapping, competitive analysis, etc. Despite the limitations in global diversity data, there are still a broad range of high-quality data which can be consolidated, standardized, and visualized to support streamlined diversity and site identification strategies. Our teams manage the complex data consolidation, ensuring global insights can be extracted to drive clinical trial equity and inclusion. TA Scan now has fully integrated diversity data, allowing users to easily streamline their KOL, PI/site selection and diversity strategies, reviewing experience and diversity or socioeconomic data in the same visualization. Data can be filtered and visualized within the TA Scan application, exported from the tool for analysis, or alternatively delivered via API.
TA Scan is a cloud-based clinical and commercial business intelligence tool that aggregates and connects global clinical trial data, presentation data, publication data, and many other data sources from the public domain into a single intuitive database. Our data represents an accurate, comprehensive view of global R&D activity, allowing users to make more informed decisions around their study designs, feasibility, site identification, and diversity and KOL identification and management strategies. The TA Scan solution provides a quick and easy way to identify and evaluate data at any desired level of detail: clinical trial data, site information, publications, expert profiles, geographical mapping, competitive analysis, etc. TA Scan’s new site capacity calculator uses historical and competitive clinical trial data from multiple global clinical trial registries to forecast site performance for an upcoming study. To do so, TA Scan reviews site workload within specified search criteria (indication, specific patient population, phase, mode of action, …), over a defined period, so the overall activity today vs historical activity levels can easily be understood. With TA Scan Site Capacity Calculator, the user can explore the site capacity for a global list of sites or for a particular site in a period at a monthly level. The new site capacity calculator supports better, more informed site selection strategies to ultimately drive faster patient recruitment!
Company: BBK Worldwide
New Product: Clinical Cuisine
Clinical Cuisine™ is a first-of-its-kind meal preparation and delivery service for clinical trial participants and their caregivers. It is designed to help patients and caregivers stay engaged and supported during clinical trial participation by removing the burden of meal planning and preparation. Through BBK's engagement platform TrialCentralNet®, Clinical Cuisine partners with local restaurants and grocery stores to deliver healthy, fresh, ready-made meals to the patient and caregiver's home while they participate in a clinical trial.
New Product: BEK Galileo v4.1.0
Galileo is prebuilt with a clinical ontology of 24 million medical terms relevant to researchers derived from more than 70,000 clinical trial protocols. The platform ingests unstructured and structured EMR data and translates it into the language and clinical terminology used in protocols, resulting in a more accurate capture of a larger pool of eligible patients. The platform also enables researchers to synthesize deeper geographic and demographic insights about the patient population across all practice groups, satellite locations, departments, and HCO facilities from a centralized source of truth.
Company: BioFortis, a Q2 Solutions Company
New Product: Labmatrix v10
Organize. Integrate. Discover. Labmatrix version 10 includes the following updates:
- Upgraded dashboard capabilities: build customizable dashboards with data-intensive visuals
- Improved performance: faster data loading & efficient handling of large audit logs
- Increased usability: bulk print barcodes & lock/unlock storage containers
- Enhanced Qiagram® features: enhanced query diagnostics & fuzzy matching to enhance data harmonization
- Delivering broader total sample management: near real-time reconciliation of eClinical data
Calyx is a recognized leader in interactive response technology (IRT). With 4,500 trials under our belt, we know what’s important to clinical trial sponsors, so we continually advance our IRT system to meet their changing needs.
Product: Clinical Trial Portfolio Website [Previously called Trial Transparency Website]
A Clinical Trial Portfolio Website is a comprehensive solution to educate, engage, and enroll participants across an entire clinical trial portfolio. Serving as a powerful patient engagement tool, these dedicated websites allow visitors to intuitively discover, navigate, enroll in, or be updated on relevant clinical research. Built with patient input and underpinned by a globally compliant data analytics platform, Clinical Trial Portfolio Websites reflect a sponsor’s commitments to transparency and DE&I while creating operational efficiency across multiple internal teams for sustainable growth. New patient engagement features include:
- Disease or Therapeutic Area Educational Pages – a dedicated page for patient-friendly disease and clinical research information. Provides plain-language patient education around a sponsor’s research with built-in questions to triage patients to individual studies.
- Community Portal – a growing community of engaged, opted-in members supported by a compliant sponsor communication engine. The public, patients, healthcare providers, and participants can join a sponsor community in multiple ways: directly from a Clinical Trial Portfolio Website, through a study microsite, if they pre-screen and disqualify, or if they pre-screen and have no active site within radius. Sponsors can then send targeted, compliant communication around disease/research education or relevant upcoming or active trials.
- Advanced Trial Matching – a clinical trial recommendation engine. Patients answer a series of questions to figure out which trial(s) they could be eligible to participate in and can then take next steps to learn more about a trial or pre-screen and enroll.
Company: Clinical ink
New Product: Digital Biomarkers Analytics Platform
Leading the way in digital biomarkers technology, Clinical ink offers the industry's best-in-class digital biomarkers analytics platform, purpose-built to capture, collect, and interpret multivariate data in real-time to power the development of new treatments.
First, the technology allows partners to validate and deliver data in real time, fusing data sources from multiple inputs, including mobile sensors, into a common reference frame. Secondly and most importantly, the platform allows for the development of disease-specific digital biomarkers, including the integration of sensor data streams to identify optimal solutions for capturing disease-relevant signals; by using time and frequency-dependent signal processing routines and algorithms; and by constructing multivariate modeling methods. Finally, with the technology, partners can measure patient response, using any digital device to capture a patient's biological response in real time, and in turn improve patient engagement and adherence, all while building machine learning solutions to improve patient-centric insights into behavior and compliance.
This platform is used in the WATCH-PD study, and, over the course of 2022, has demonstrated 92% accuracy in classifying early Parkinson’s patients from healthy volunteers—thus, demonstrating that more frequent and extensive remotely monitored measures hold the potential to yield greater insights into disease progression. The next step is to seek regulators’ qualification so these digital biomarkers can be used as primary endpoints. Ultimately, the goal is for these measures to be adopted industry-wide as a way to help diagnose movement disorders, screen patients for trials, and evaluate the efficacy of treatments in development.
New Product: ClinOne Insights Version 2.0
ClinOne Insights v2.0 provides sponsor and site users with access to data and metrics across their entire study portfolio. With three clicks, users can navigate to a dashboard that presents metrics on consent activities across all their studies. There are currently four reports available out of the box, with the ability to modify these by filtering and drilling down into specific data points: Consent Usage, Consent Signatures, Consent Aging and Consent Video Calls. This new dashboard area of the ClinOne portal and the four reports mentioned above are brand new for this release. This solution allows sponsor and site users to understand how consent activities are being managed and delivered for their studies; for example, having a real-time look into compliance and understanding site and participant engagement with the consent process. These insights can then fold back into protocol design to enable a data driven approach to enhance the clinical trial experience. Better yet, this solution resides within the same portal that users would use to conduct their other daily research activities: there are no separate logins, no external URLs, etc. ClinOne understands the burden presented when users must navigate multiple systems and we’ve addressed that with this release of Insights v2.0.
Company: Continuum Clinical
Product: MERIS Total Engagement Solution
The MERIS Total Engagement Solution is a new product that is being introduced for the first time at SCOPE. It is a suite of globally compliant clinical trial enrollment and retention products, which enables a seamless clinical trial experience for study participants and research sites while producing real-time, actionable performance data for sponsors. MERIS interacts with patients throughout the clinical trial enrollment journey, giving Sponsors the ability to identify precise barriers and opportunities that are impacting enrollment and retention – enabling real-time course-corrections and adjustments, which help mitigate preventable delays, and solve enrollment problems without guesswork. The MERIS Total Engagement Solution includes: --- MERIS Enrollment: A globally compliant technology solution that prescreens and connects qualified study participants to research sites. ---MERIS Retention: A communication platform that motivates study participants by enabling direct to patient interaction throughout screening and enrollment to remind them of upcoming visits, collect real-time feedback, and encourage participation to enhance their clinical trial experience. ---MERIS Analytics captures, visualizes, and simplifies the data collected from the Enrollment and Retention Solutions, which provides real-time performance measurement. MERIS interacts with patients throughout their clinical trial enrollment journey, allowing anyone responsible for enrolling and retaining patients in clinical trials to refer to critical data points and course-correct in real-time, avoid costly delays, and solve enrollment problems without guesswork.
New Product: openFDA Drug Interaction Visualizer V1.0
Cyntegrity's Drug Interaction Visualizer is a powerful tool that allows clinical research professionals to explore potential drug interactions between commonly prescribed medications. The tool is based on real-world data collected by the FDA between 2015 and 2021, containing more than 17,000 most prescribed FDA-regulated drugs with adverse event reports.
The visualizations provided by the tool enable users to quickly identify potential risks or benefits associated with different drug combinations, and to delve deeper into individual drug profiles to examine data trends over time, by gender, and by age.
Additionally, the tool provides a user-friendly feature, Generate Report, which allows users to easily save and share their findings. One of the key strengths of the tool is its transparency. The visualizer provides detailed information on how to read the data, and how the data has been prepared, such as data extraction, generic name classification, medicinal product name to generic name mapping, and text parsing. Additionally, it includes information on the limitations and considerations of the data, such as the fact that the number of prescriptions of a drug or the number of packages sold may be very different for various drugs and has not been taken into account in the analyses provided. Furthermore, the data is updated regularly and can be accessed from 2001 to 2021 via openFDA Dashboard page.
Company: Deep 6 AI
New Product: Deep 6 for Life Sciences
Our AI technology is reshaping clinical research from protocol creation and site selection to patient recruitment. Using our cohort builder tool, researchers build a study on our platform by inputting the inclusion and exclusion criteria, or simply entering the NCT number (which pulls data from the government website).
The largely untapped source of unstructured data in EMRs is typically only searched manually. Once a study is built, our technology utilizes natural language processing (NLP) to read through a healthcare system’s entire EMR, including both structured and unstructured data, to pull together a list of matching patients for that trial. These patients then need to be validated by the user. With machine learning, the tool becomes more precise over time. Using our innovative technology, we help principal investigators, clinical researcher coordinators, and research administrators streamline their outdated research processes to focus on bringing new therapies to patients.
Our ecosystem is constantly adding new research sites including hospitals, CROs, academic medical centers, life sciences companies and more. With dozens of major healthcare organizations in our system, including NCI designated cancer centers, we have more than 1100 individual sites, and more than 19 million patients. This network of sites, together with our network of top-tier pharma and biotech companies of all sizes form our ecosystem. These companies utilize our software to pinpoint the best sites in our system to run their studies. Our products help sponsors find the right patients for the right trials at the right time to succeed.
New Product: Community Research Site
EmVenio’s Community Research Sites are delivering localized trail access to diverse and underserved communities. We empower patients and embrace communities on their terms. Our research solutions cultivate a sustainable local ecosystem that benefits all stakeholders. Removing barriers and unlocking doors to innovation reduces risk and time associated with clinical research while improving ROI. EmVenio Research’s global network of skilled clinicians, principal investigators, and state-of-the-art Community Research sites enables us to provide services via home visits, onsite support at medical facilities, virtual visits, and mobile sites. EmVenio offers multiple Community Research site models with multiple exam rooms and certified lab capabilities.
Company: Endpoint Clinical
New Product: Audit Data Management Platform
To maintain data oversight and ensure integrity, Health Authority guidelines require IRT audit log data to come directly to Investigators without Sponsors handling or managing the data in the process. To meet this requirement, IRT vendors must facilitate Investigator access to system audit logs post study close, outside the IRT system. To solve this challenge, Endpoint Clinical® partnered with Egnyte® to create a secure, GXP-compliant platform that delivers clinical trial audit log data to Investigators at the end of the trial directly from the IRT upon study closeout. The platform solution uniquely provides controlled access to the site-specific data to each Investigator while also providing the Sponsor documented proof that the audit log was distributed to the Investigator. In this manner, the Sponsor can fulfill their obligation to enact oversight of the process and have assurances of ALCOA+ principles without being an intermediary. The clinical trial and regulatory landscapes are continuously changing, and through Endpoint’s commitment to bringing innovative solutions to our customers and stakeholders, we are excited to be able to offer this new capability to Sponsors and Investigators of all the trials we support.
InnovoCommerce’s product, SiteCloud, is a site-empowering, multi-sponsor collaborative cloud with artificial intelligence capabilities and regulatory workflows built to address rare disease, treatment, prevention, and other trials of any size and complexity. From study startup to closeout, SiteCloud provides the ability to virtually qualify sites and remotely collaborate with them in their preferred method of communication, including chat, call, and video. Its robust eISF includes source, site, and regulatory documents in one spot for seamless, real-time access. This allows onsite visits by the monitor to be effectively supplemented with the remote monitoring model. Additionally, the AI model processes source documents and automatically redacts sensitive content, extracts metadata, auto-classifies them, and assists the study nurse to rectify potential issues based on its evolving model. With its compliant design and high degree of accuracy, this innovative approach dramatically reduces the site staff’s burden and eliminates the redundancy of tasks that are performed at the site level. With SiteCloud, sponsors experience reduced costs and a significant improvement in their clinical trial’s data accuracy, integrity, and completion.
New Product: IQVIA's Integrated IRT eCOA Platform
Launched in May 2022, IQVIA’s IRT eCOA orchestration solution goes beyond point-to-point integration to deliver a solution that extends the power of the individual platforms to produce an additional set of features and capabilities. In addition, the coordination of services simplifies and accelerates study design and conduct for teams using IRT and eCOA. IQVIA’s IRT eCOA solution delivers improved flexibility and compliance by eliminating duplicate data entry and expediting critical workflows, such as patient screening, enrollment and randomization. For example, patient enrollment data entered into IRT flows directly into eCOA to reduce site burden and the risks of data entry error. Likewise, screened data from eCOA flows directly into IRT so eligible patients are automatically flagged for randomization, stratification and treatment arm designation. These are two of the many workflow optimization steps built to reduce effort and improve study quality. By minimizing manual data entry, sites can reduce time spent on redundant tasks as well as error potential and feel empowered to spend more time on value added activities that fully utilize their skill sets and training, such as spending time with patients. Finally, unlike operating trials using individual, unintegrated IRT and eCOA platforms, the unified approach enables quick access to data, resulting in faster, improved decision-making.
New Product: IQVIA Asset Intelligence Tool Version 1
The IQVIA Asset Intelligence Tool is an all-in-one, machine learning application that provides predictions on the likelihood of a therapy's technical effectiveness and its probability of gaining regulatory approval. The application allows users to see all current trials for an indication, allowing sponsors to understand how and when competitive assets will be approved.
Insights from this tool can be used as a reference for clinical trial designs. For example, comparing inclusion/exclusion criteria being used in other trials can help improve your design by following similar criteria.
It aggregates clinical research information from a myriad of sources, such as PubMed, Drugbank and Clinicaltrials.gov, along with other trusted data resources, into an extensive database of all phase I-III clinical trials. The application’s predictions are based on nearly 80,000 clinical development programs with comprehensive clinical trial and regulatory approval datasets enriched with more than 1,800 variables, including: Interventions, therapeutic class, molecular structure, toxicity and related scientific articles; Patient populations, therapeutic area, indication, age and inclusion/exclusion criteria; and Trial data, development phase, trial characteristics, countries, sites, investigators and comparators.
This AI/ML-based calculation of probability of technical and regulatory success (PTRS), with detailed prediction drivers for context, such as trial geography, historical success of similar drugs, and clinical trial design variables, enables sponsors to understand potential risks involved with investments or clinical program decisions.
New Product: Korio's RTSM v1
Korio’s products are built on a cloud-native, security-first platform leveraging a microservices framework; our architecture enables continuous product feature innovation and platform capabilities expansion with lower overhead and Quality by Design.
- Study Setup Reusability: Saves inputs from your previous clinical trial builds, enabling study settings and system configurations to automatically be reused on subsequent clinical trials.
Roles-based Navigation: Speaks to different user segments to automatically populate data and provide a more personalized and seamless experience in later workflows.
Auto-Generation of RTSM Requirements: Creates and manages your entire RTSM documentation suite including RTSM Requirements for less overhead and more accuracy in RTSM setup, maintenance and enhancement phases.
Integrations Setup Wizard: Syncs your Korio RTSM data with the industry's most frequently-used clinical systems with less heavy lifting and errors. Custom integration templates are set up as needed to be re-used for future trials.
Intuitive Workflow: Navigates users through all aspects of RTSM system use to ensure every Korio RTSM interaction is completed with confidence.
Monitoring: Runs real-time diagnostics on your RTSM system to provide assurances of availability, performance and overall system health.
- Expanded Help Center: 24x7x365 community-driven support coupled with an easy-to-reach live helpdesk provides ready-access to the most up-to-date help and resources to ensure Korio users feel set up to succeed.
New Product: Primarius 3
Patient expenses and reimbursement management, travel and logistics, study information and access to 24/7 support in multiple languages. The new release includes stipend functionality and improved payee management. It has the capability to assign Healthcare practitioners, paper source documentation, contract allowance and more. Primarius 3 has a newly updated admin portal, which includes visit management and scheduling, protocol management, visit checklists, claims to process, payment batching, and reporting. It has a patient app, which is available in 50 languages and includes the participant profile, claims submissions and travel requests and a desktop version which replicates the app for those who do not wish or are unable to use a mobile phone.
Company: Medidata, a Dassault Systemes Company
New Product: Detect
Medidata Detect is a modular, interconnected, single sign-on, cloud-based clinical software solution for data quality and risk monitoring. Detect aggregates and analyzes data from many sources to provide a unified picture of the risk inventory, patient journey, site performance, and the overall trial health. Many different types of clinical data can be automatically integrated in one place, including sensors, eCOA, central lab data, EDC, and safety data, to drive unified, configurable workflows for multiple operational users. Detect activities include initial and ongoing risk planning and assessment, planned risk monitoring via KRIs, QTLs and targeted analyses, anomaly detection via machine learning driven checks, automated data cleaning using preset data listings and bulk query management, and safety reviews with narrative patient profiles - all functionality that improve patient safety, data quality oversight and risk management. Trends, insights, and risks are surfaced in intuitive visuals and dashboards that are fully integrated with an issue management interface. Detect analyses are powered by machine learning, AI, and intelligent process automation to significantly improve clinical research efficiency. In 2022, Medidata released several significant upgrades to Detect’s functionality. Its capabilities are now fully modularized by activity, enabling different types of users to complete the activities and workflows that best suit their needs. Detect modules support multiple functional roles including data managers, CRAs, central monitors, medical monitors, clinical project managers, and site investigators. Detect also released brand new data surveillance capabilities, providing data managers with robust data interrogation, review, and reconciliation workflows, including smart query generation and automated query posting.
Company: Medidata, a Dassault Systemes Company
New Product: Intelligent Trials Diversity Module
The Intelligent Trials Diversity module provides insights that enables biopharmaceutical companies and CROs to take action and improve study diversity during the planning stages of a trial. With this tool, users can find sites that not only will perform well operationally but have also demonstrated the ability to recruit diverse patients, helping them to make qualified decisions about site selection. This first-of-its-kind solution leverages Medidata’s industry-leading historical clinical trial data repository of more than 8 million patients from 29,000+ clinical trials to provide an integrated view of site performance and demographic data. The Diversity module captures four main demographic variables – age, sex, race, and ethnicity – using processes to standardize these variables across all trials according to CDISC standards and aggregate data for statistical insights. With this solution, users have the ability to filter and sort through a site list in a particular indication, and choose the best performing sites while simultaneously evaluating site experience, operational performance, and diversity metrics. They can also benchmark the diversity of their current and previous trials in a specific indication compared to industry trials, helping them identify gaps and reasonable diversity goals. This module, launched in July 2022, expands upon the existing Medidata AI Intelligent Trials solution, which offers insights across the study life cycle from study planning to execution. Insights from this solution provide confidence in decision making; visibility into trial and industry performance; and agility to navigate a dynamic trial landscape and gain a competitive edge – all to help bring treatments to patients faster.
Company: Medidata, a Dassault Systèmes company
New Product: myMedidata App (v1)
The myMedidata App, launched in December 2022, is a patient-centric, native app designed to provide trial participants with a seamless platform experience and single login for all of their remote trial activities. Patients can engage with their clinical trial activities from the comfort of home, at a hospital, or wherever their day may take them. A patient’s personal device (BYOD) or a management services device (provisioned), with either iOS or Android systems, is supported with this flexible, go-anywhere technology. Ultimately, this unified myMedidata experience will give patients more choice in how they participate in clinical trials, whether through the web, the app, or a combination of both, depending on the study design. The myMedidata app is unique to the industry, being unified with the Medidata Platform, including Rave EDC (electronic data capture). This results in an entirely self-sustaining ecosystem where patient input, site based activities, and behind the scenes data management seamlessly operate together. The app is configured using Medidata Designer, a new platform configuration tool, bringing a patient-centered mobile-first workflow builder to the myMedidata app. With Designer, sponsors and CRO partners can build a rich patient experience via intuitive drag and drop screen templates and visual workflow tools. This simultaneously sets up a clinical database in the background without the need for any custom code. Designer drastically lowers study build times by employing Medidata and client libraries, including pre-built eCOA instruments, translations, and study configurations.
Company: MERIT CRO
New Product: EXCELSIOR v 4.5.0
EXCELSIOR™, MERIT’s comprehensive, cloud-based software solution, elevates efficiency and accuracy in the collection and interpretation of clinical trial imaging data. EXCELSIOR is built to meet regulatory requirements including HIPAA, 21 CFR Part 11, GDPR, and HGRAC. The application utilizes the latest web and imaging technologies for data standardization, analysis, reading, and reporting. Its cloud-based single system provides complete data accessibility and transparency. EXCELSIOR’s centralized data system features customizable workflows and audit trail tracking. This allows all study stakeholders (sponsor representatives, CRAs, site and reading center personnel) unparalleled accessibility to image data to perform imaging tasks from globally dispersed locations. EXCELSIOR’s FDA 510K clearance as a class II medical device was recently expanded to include managing radiological as well as ophthalmic clinical trial data. Users are only required to use a standard web browser (Google Chrome, Mozilla FireFox, Microsoft Edge, Safari) and allow certain domains through the firewall. No other technical specifications are required. EXCELSIOR simplifies image management workflows, increasing efficiency in the upload, management, review, and grading of images for clinical trials. This delivers quicker, more precise results, with less risk.
New Product: Pro-Active Protocol
Pro-ficiency’s new Pro-Active Protocol solution is a proprietary protocol optimization methodology that translates protocols into animated, interactive study schemas. By visualizing the study prior to implementation, sponsors can identify potential implementation challenges and inconsistencies and gain a level of understanding of the study that is essential for driving study quality and compliance. With the end goal of a better-designed study, Pro-Active Protocol delivers a highly visual representation of your study’s operational workflow and patient journey that improves how:
- Sponsors proactively identify protocol inconsistencies or gaps and improve operational understanding of the study for all involved
- Potential subjects can envision their journey through the study
- Sites plan for the resource and operational demands of the study
- Regulators and ethics committees understand the complexities of the study design that can’t be fully appreciated through a static schema diagram
Grounded in Pro-ficiency’s signature simulation technology, Pro-Active Protocol integrates seamlessly with study training modules or can serve as a stand-alone resource, to increase study and site team understanding of the study requirements upon study start-up. Pro-Active Protocol is developed using a proprietary visualization methodology and hosted on the Pro-ficiency platform as a virtual resource available online 24/7. The Pro-ficiency platform facilitates rapid updates as study parameters are edited or amended, and can be distributed globally in an instant with live tracking and compliance analytics available to study leads.
New Product: Co-Pilot for Sites and Patients
- All in one, personalized, study specific digital workflow, accessible as a web application across any internet enabled device.
- Tasks are tied together with powerful logic rules that may include dependencies on roles, data, time (to the minute level), date, completed tasks, demographics, location and any other passively/actively collected inputs.
- Global User IDs to reduce log in confusion and complexity
- API integrations available to any 3rd party applications and services including, data capture , logistics, RTSM, biosamples, connected devices, CTMS, payments, and calendars.
Company: RealTime Software Solutions
New Product: ‘ENGAGE!’ solutions featuring MyStudyManager and eCONSENT - Version 1
MyStudyManager™ is a participant- and site-centric tool that was created to be adaptable to various forms of clinical research, while also allowing the participants to have a central place they can refer to for important study information. With this user-friendly mobile and desktop application, the sites are able to have timely and effective communication with their study volunteers. MyStudyManager™ provides the participants with access to a comprehensive dashboard, calendar of events, study consents, stipend information, ePRO documents, centralized site contact information, and compliance-driven study notifications. The application includes virtual visit capabilities to support improved relationships between the study team and the participant. At the conclusion of all visits, the sites also have the opportunity to send the participant a satisfaction survey to learn more about how they can improve their research practices. Obtaining informed consent is the first critical step in gaining a volunteer’s participation in a study, so eCONSENT was added to streamline the consenting process. eCONSENT is a simple yet robust solution that complements the site’s existing workflows. Sites are able to promptly upload in their consent documents, prepare the document(s) for eCONSENT, route the document for signature, and then acquire all Part 11 compliant electronic signatures in an efficient manner. Within RealTime-SOMS, the site can connect their eCONSENT document to their delegation log in addition to having compliance popups and visual cues throughout the system to decrease consenting errors.
Company: Red Nucleus
COVID-19 and the global pandemic are household words to everyone. There is little doubt that the environment has created a catalyst to look at new ways and technology to facilitate the collection of clinical trial data. Beyond Survey’s and ePRO, there has been a surge in telehealth/live video calling, but not without challenges to privacy and security. The iTakeControl platform enables the collection of audio, video, images, and documents anywhere a patient may be with fully automated de-identification in a validated and 21CFR Part 11 compliant system. A live video call can be recorded and used as source data in a clinical trial for review, scoring, and retrospective analysis as opposed to simply a video visit.
Company: ScienceMedia, Inc.
New Product: SMi Trial (2023)
SMi Trial, a protocol compliance and risk-based training solution for clinical trials, reduces screen failures and protocol deviations, while improving data quality, study start-up times, and patient safety. The engaging protocol-specific multimedia, built by a team of PhD clinical and therapeutic area specialists, identifies protocol misunderstandings for staff, and bridges the gap of trust and understanding for all patients. Used by site staff, mobile health workers, study teams, and patients, SMi Trial communicates protocol amendments and is a portal to all vendor materials and systems and requires minimal effort from sponsors by taking training burden off study teams. With SMi Trial, clinical trials have completed 20% faster and saved millions in operating costs.
Released in Fall 2022, SMi Trial’s latest upgrades incorporates the patient voice into trial design by featuring new patient-facing training and includes new materials that support patient diversity. SMi Trial provides translation capabilities and is designed for user-friendly consumption.
By leveraging data and technology to improve patient centricity and engagement, SMi Trial offers patient-oriented education that assists patients and optimizes study compliance throughout the entire clinical trial process. Engaging videos prepare patients for doctor visits, home healthcare visits, and details expectations around the consent process. As opposed to archaic ways of waiting to find issues long after they were made, SMi Trial can identify misunderstandings early and thus mitigate before more time passes.
Company: Strategikon Pharma
New Product: Clinical Maestro 4.0
With significant SME input, the Clinical Maestro team designed the industry’s first dynamic bid grid mapping technology to automate the current costly and highly frustrating process employed by both Sponsors and CROs and reduce the manual effort by >95%. With 2-way mapping feature Sponsors have the option to map their unique template (unit, fixed or hybrid template) to Clinical Maestro’s to create an instant mapping key, which then allows them to model clinical study costs, create RFPs and change order requests in their structure, while retaining the ability to benchmark costs with the powerful Clinical Maestro databank. The CROs continue to submit proposal budgets in the Clinical Maestro structure, continuing the well established process. Further, with breakthrough 3-way mapping technology, the CROs can also map their unique cost structure to Clinical Maestro, allowing them to submit proposal budgets in their native costing tool output. The mapping key is self-configurable and fully automated, resulting in a high degree of accuracy and repeatability. Finally, the CROs who leverage the Clinical Maestro costing tool CORE™, can use both 2-way and 3-way mapping to generate and maintain any Sponsors’ bid template and benchmark proposals to market. Clinical Maestro new mapping feature increases transparency, accuracy, and collaboration of the proposal budget process, eliminates mapping and reporting errors, and drastically reduces the resource effort allocated to mapping, budget negotiation and reporting. Ultimately, all parties save time through accelerated due diligence and pricing processes, contributing to >10% reduction in the cost of clinical development by lowering project management and infrastructure expenses.
New Product: StudyCash
StudyCash is entering the market as the first international patient payment application allowing sponsors to easily reimburse patients across the globe, resulting in greater participant accessibility. Patients can operate the application in their native language and select their method of reimbursement in local currency, resulting in greater accessibility and accelerated trials. No physical card is required and no fees are ever charged to the patient. The only thing required is access to a mobile device and StudyCash takes care of the rest. As part of StudyKIK’s end to end clinical trial management platform, StudyCash was developed as a centralized tool to help better connect patients around the world to clinical trials.
StudyCash is a convenient and secure system that allows study participants across the globe to request payment for their study related activities and expenses. Once approved, patients can collect their reimbursements through direct deposit, gift cards, donations, and more. Supported by Auth0 security, StudyCash maintains and meets the requirements of multiple compliance frameworks and certifications including GDPR and HIPAA. Compatible with Android and Apple, StudyCash is available on iOS, Android OS, Windows OS, Mac OS, Chrome, Edge, and Safari.
New Product: US Investigator Performance Database
The Sunshine Investigator Tool draws upon data from Open Payments, ClinicalTrials.gov and SunshineMD proprietary classification and modeling systems to construct a user accessible database of virtually every active US clinical investigator since the end of 2013. For these 75,903 investigators in Open Payments, the SunshineMD database contains critical information, including:
- Almost every study each investigator has worked on.
- Each investigator’s enrollment performance compared to every other US investigator on a given clinical trial.
- Investigator specific summary enrollment and start-up performance scores across all the studies on which that investigator has worked compared to any subset of investigators in the US investigator population, e.g., by specialty.
- Investigator contact information.
For virtually every pharmaceutical industry study the following information is also available in the SunshineMD Investigator Tool:
- The names and contact information of the US investigators who worked on that specific study
- How well each of the investigators working on that study enrolled compared to all the other investigators on that specific study.
- Study design details and key dates.
To test the accuracy of our enrollment measurements we examined our enrollment data against actual patient enrollment data from five major CROs and sponsor companies. The rank order correlation between our enrollment data and the actual study data supplied by the clinical trial organization regularly exceeded .9+.
Product: Trialbee Honey (now with Omnichannel and Analytics)
It is clear and certain that single-tactic recruitment strategies running across disparate and disconnected technology solutions is no longer sufficient. Trialbee introduced Omnichannel in November 2022 as a game-changing solution for multichannel patient recruitment focused on a specific indication and its associated patient communities.
New Product: uMotif eCOA/ePRO and Engagement Platform: First New Validated Innovation in eCOA/ePRO Since Paper Instruments Were Deployed on Smartphones
uMotif offers an eClinical cloud native eCOA/ePRO platform for site-based, hybrid and fully decentralized clinical, real-world, and post-marketing research trials. The cornerstone of uMotif’s offering is the Motif – a patented, flower-like graphical user interface to capture PRO, symptom and eDiary data. Each petal of the flower represents a different question, such as an Outcome Measure, symptom, or eDiary entry. Patients simply swipe on the petal to capture their data. It is fast, simple, engaging and accurate. The Motif was validated by independent research organization SAFIRA Clinical Research at Dublin City University. Fifty-five participants completed testing in two randomized groups using the Motif interface and a traditional 5-point Verbal Response Scale (VRS-5). The study results collected and analyzed by SAFIRA showed equivalence between the Motif interface and standard VRS (high ICC) for capturing VRS data. This makes the Motif the first innovation in eCOA/ePRO since paper questionnaires were migrated to smartphones. Equivalence testing was based on the most commonly used PRO, the EQ-5D-5L, which was provided for the study with support from Euroqol. Study results are expected to be published in 2023. The Motif gives researchers an entirely new and alternative way to encourage patients to capture data. Patients enjoy using the interface because it was created by a team of global experts in consumer design, as well as clinical trial technology. It is generating unprecedented amounts of data capture.
Company: Veeva Systems
Veeva CDB, a first-of-its-kind solution for aggregating, cleaning, and transforming clinical data. Veeva CDB enables clinical teams with a clinical data platform for ingestion and review of all study data sources while reducing the manual processes, integration projects, complexity, and costs associated with making clinical trial data usable. Its automated ingestion engine brings together data from a wide range of external sources, including EDC, RTSM, ePRO, eCOA, and lab data. Embedded capabilities, such as change detection, auto-checking of data, and centralized query management can significantly streamline clinical data management processes.
The Veeva Digital Trials Platform is a solution to significantly advance clinical trial execution by providing a complete and connected technology ecosystem that spans patients, research sites, and trial sponsors. The product offering delivers solutions built for the unique needs of patients (MyVeeva for Patients), research sites (Veeva SiteVault), and sponsors (Veeva Vault Clinical Suite). Veeva ePRO, an application that makes it easier for patients to complete assessments on a mobile device or web browser and enables real-time data access for sponsors and clinical research sites, was recently added to the Veeva Digital Trials Platform.
New Product: YonaLink’s next generation EDC ver. 3.4.1
YonaLink’s all-in-one, next generation EDC platform is purpose-built to stream data and includes the following features:
- Automatic mapping streamed data from EHRs to the correct fields in eCRFs within EDCs, addressing the long-standing industry challenge of duplicate data entry
- System agnostic enabling global interoperability with any EHR worldwide
- Seamless integration with any modern eSource tool without coding changes
- True end-to-end workflow based on CDISC standards
- Built-in eConsent and ePRO / eCOA capabilities and streaming EHR-to-EDC capabilities, YonaLink provides a comprehensive solution for today’s clinical trial needs, bringing EDC and eSource functionality together in a single tool
- Easy-to-use capabilities including seamless protocol setup and amendments, advanced edit checks, data blinding management, randomization, medical imaging, and more
- YonaLink’s platform simplifies the complexity of clinical data collection and validation thus enabling true scalability.
Company: YourBio Health
New Product: TAP Blood Collection Devices
TAP® is the world’s first push button blood collection device and eliminate barriers to blood collection. Our technology allows a patient blood sample to be collected from any location without the pain of a fingerstick or need for traditional phlebotomy. We enable the decentralization of clinical trials with our virtually painless, easy-to-use, patient-centric device. TAP enables the collection of a high-quality blood specimen from any setting – clinical or in-home. The device can collect up to 1 mL of whole blood and collects a minimum of 200µL with greater than 95% success rates. TAP is available with a variety of tube additives, including clot activator for collection of serum samples, lithium heparin for anticoagulated and plasma samples, and separator gel for ease of sample separation at the lab. TAP products can be supplied in bespoke kits and paired with custom software to deliver easy clinical trial management and seamless user experience.