• If We Were Designing Clinical Research Today, Would We Still Separate Source Documentation from Data Capture?

    Sep 16, 2026, 01:01 by User Not Found
    Clinical Research News | Clinical research has never been only about generating evidence that a therapy is safe or effective. It is equally about generating confidence in the evidence itself. Every observation, every assessment, every protocol deviation, every adverse event, every laboratory result, and every conclusion must be supported by documentation that can withstand scrutiny. We work in a profession built on verification. “Trust but verify” is woven into our quality systems. “If it wasn't documented, it wasn't done” is probably the most recognized sentence in our field.
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  • Psychedelic Medicines Approach a Historic FDA Approval Milestone with Safety Under Scrutiny

    Sep 15, 2026, 10:39 by
    The FDA's historic psychedelic hearing highlighted a critical question: how can psychedelic medicines become accessible without compromising patient safety? As developers move closer to potential approvals, regulators must balance clinical evidence, professional oversight, workforce training, geographic access and long-term safety.
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  • FDA Approves AstraZeneca’s Etcamah, Bringing ctDNA-Guided Treatment to Breast Cancer

    Sep 14, 2026, 10:16 by
    AstraZeneca’s Etcamah has received FDA accelerated approval for ctDNA-guided treatment in HR-positive, HER2-negative breast cancer with ESR1 mutations. The decision could establish an earlier treatment-switch strategy based on molecular changes before cancer becomes visible on scans.
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  • FibroFind appoints leading transplant physician Professor Andrew Fisher as Chief Medical Officer

    Sep 14, 2026, 10:16 by
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  • UT-led study finds COVID-19 can awaken hidden viruses throughout the body

    Sep 14, 2026, 10:16 by
    Researchers say dormant viruses many people harbor can reactivate during COVID-19 and may be linked to long COVID symptoms.
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  • Panther Life Sciences Appoints Mounir Hanana as Chief Executive Officer

    Sep 14, 2026, 10:16 by
    Hanana brings 25 years of experience scaling global technology, consumer, and manufacturing businesses at Amazon and Procter & Gamble. Founder Carlos Bhola continues as Executive Chairman, leading strategy, product vision and corporate development. Hanana joins as Panther begins commercializing its SmartPatch™ platform, starting with cosmetics and medical aesthetics and expanding to therapeutic applications.
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  • Qinecsa selected as technology partner for Africa’s new continent-wide medicines safety platform

    Sep 14, 2026, 10:16 by
    Qinecsa has been selected as technology partner for AfriVigilance, the African Medicines Agency’s new continent-wide medicines safety surveillance platform, with implementation already underway.
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  • Research uncovers new driver of immunotherapy resistance in pancreatic cancer

    Sep 14, 2026, 10:16 by
    Targeting a signal released by dormant cancer cells could help overcome resistance to immunotherapy and improve cellular therapies for pancreatic cancer.
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  • Peer-Reviewed Study Published in MDPI’s AI Journal Shows NetraAI Uncovers Clinical Trial Signals Missed by Conventional AI and Foundation Models

    Sep 14, 2026, 10:16 by
    The study evaluated NetraAI across clinical datasets in schizophrenia, major depressive disorder and pancreatic cancer, benchmarking the technology against eight industry-standard predictive models. Results show NetraAI's biological and clinical signatures successfully boosted the accuracy of all eight evaluated algorithms across every single dataset tested.
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  • The Adherence Imperative: Clinical Operations and Patient Centricity

    Sep 11, 2026, 01:01 by User Not Found
    Clinical Research News | Participant adherence is a leading indicator of trial health. Adherence reflects patient centricity as a measure of how effectively a clinical trial has removed barriers, supported participants throughout the study journey and enabled sites to deliver a high-quality participant experience. As participant experiences improve, usually so does adherence, especially considering that approximately half of all dropouts in phases 2-3 come down to participant choice rather than adverse reactions or study staff decisions.
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  • Biocon Secures 10-Year Supply Contract for Pertuzumab in Brazil

    Sep 9, 2026, 13:58 by
    Biocon has secured a 10-year PDP allocation for pertuzumab in Brazil through a partnership with Bahiafarma and Bionovis, covering around 70% of the country’s public-sector demand. The agreement combines long-term supply with phased local production, supporting affordable cancer treatment access and strengthening Brazil’s domestic biopharmaceutical capabilities.
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  • MIB Agents Now Accepting Letters of Intent for 2027 OutSmarting Osteosarcoma Research Grants

    Sep 9, 2026, 13:58 by
    MIB Agents, a leading pediatric osteosarcoma nonprofit dedicated to Making It Better for its community of patients, families, medical professionals, researchers and industry partners, is accepting letters of intent (LOI) starting on Wednesday, September 9, for its annual OutSmarting Osteosarcoma research grant program.
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  • Yourgene Health Insight DPYD Assay Achieves IVDR Accreditation

    Sep 9, 2026, 13:58 by
    Comprehensive pharmacogenetic testing solution aligned with latest clinical guidance to support informed chemotherapy treatment decisions
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  • CluePoints Launches Three AI-Led Clinical Data Review Capabilities, Co-Innovated with a Top 10 Pharmaceutical Company

    Sep 9, 2026, 13:58 by
    Intelligent Query Detection, Medical & Safety Review and Intelligent Medical Coding are now generally available, extending CluePoints' science-first approach from RBQM into clinical data review. The partner will join CluePoints live at SCDM 2026 to celebrate the launch.
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  • Global Effort to Overhaul Regulatory Framework for AI Medical Devices

    Sep 8, 2026, 14:17 by User Not Found
    Clinical Research News | Data routinely captured to track health and measure wellness do not reflect ground truth, as is well known in the field of medical informatics. That imperfect healthcare data is nonetheless being used to train artificial intelligence (AI) models powering devices used in patient care, often having never been evaluated on their clinical effectiveness.
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  • Integrion Automation Builds on Its Medical Device Capabilities to Support Validated, Traceable Production

    Sep 3, 2026, 09:02 by
    Integrion Automation provides validated, traceable automation solutions for medical device manufacturers, helping improve quality, compliance, and flexibility in regulated production environments. Its GAMP 5-based approach, validation services, advanced inspection and assembly technologies, and lifecycle support help manufacturers reduce risk while maintaining audit-ready operations.
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  • Inceptua Acquires SupplyRx to Enhance Pharmacy Services for Clinical Trials

    Sep 3, 2026, 09:02 by
    Inceptua Group today announced the acquisition of SupplyRx to enhance pharmacy services for clinical trials.
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  • The Scope of Things: Source Preparation Emerges as a Clinical Trial Startup Bottleneck

    Sep 3, 2026, 01:01 by User Not Found
    Clinical Research News | Clinical trial startup delays are often attributed to budgets, contracts, and regulatory review, but a less visible bottleneck may occur at the investigative site level: source preparation. During the latest episode of The Scope of Things, Ken Getz, executive director of the Tufts Center for the Study of Drug Development, and Rick Ward, chief commercial officer at CRIO, discussed their companies’ collaboration exploring how preparing source documents delays getting the first patient in and slows enrollment.
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  • Researchers Gain Faster Access to Complex DNA as Integrated DNA Technologies and Ansa Biotechnologies Expand Ordering Platform

    Sep 2, 2026, 08:45 by
    Integrated DNA Technologies (IDT) and Ansa Biotechnologies expand partnership, making it easier for researchers to access longer, more complex DNA.
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  • FDA's Real-Time Clinical Trials Initiative Takes Shape: What Near-Live Data Sharing Means for Sponsors and Operations

    Sep 1, 2026, 01:00 by User Not Found
    Clinical Research News | The FDA's Real-Time Clinical Trials (RTCT) initiative is testing whether earlier access to selected clinical trial data can improve regulatory oversight by allowing reviewers to observe selected safety and efficacy signals while studies remain underway. Under the proof-of-concept pilot announced in April, participating sponsors share agreed-upon data elements rather than giving FDA reviewers unrestricted access to complete trial databases.
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