A biostatistics consultant on the pattern she keeps seeing: sponsors skipping steps to chase accelerated approval.
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ON-DEMAND WEBINARS
Explore how CTMS capabilities can help uncover hidden study risks with industry-standard questions in the CTMS library, score study risk based on likelihood, impact, and detectability, and manage key risk indicators.
See how AI handles real site documents in real time and walk away with a practical, honest look at what modern data capture could mean for your trial operations.
Leaders from AstraZeneca, Syneos Health, Sarah Cannon Research Institute, and Medable get candid about where agentic AI is actually earning its keep.
An eTMF system can help Clinical Operations professionals manage the deluge of documents and data, but what capabilities are right for your situation? What is the best way to make the move to a modern eTMF from paper, spreadsheet trackers, or legacy tech to a new eTMF? Hear answers to these questions and more from a fellow Clinical Operations leader with experience in making the transition to an eTMF built for today's research ecosystems.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Pioneering Clinical Research For Native American Communities In South DakotaLynn Bartholow is transforming clinical research for Native American populations. Explore her journey into clinical research and efforts to build trust and foster participation and community engagement.
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Vanderbilt's Advice For Sponsors: How To Make Working With Your EDC Easier For SitesLearn how research sites like Vanderbilt University Medical Center speed study timelines and drive higher quality data entry with a modern EDC.
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Endpoint Reliability And eCOA Solutions Facilitate CNS Trial SuccessA Japan-based pharmaceutical development company utilized Signant's eCOA solutions and knowledge to ensure the reliability of endpoints in their Phase 3 and extended-duration CNS trials.
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What Does EDC Look Like In 2024 And Beyond?Read along as industry experts from TrialKit offer insights into the anticipated developments and challenges surrounding electronic data capture.
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Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary StudyDiscover how a clinical development program was saved using objective, continuous digital outcome measures.
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Real-Time Review Is The Most Underrated FDA Story Of The YearThe FDA’s real-time review pilot signals a massive shift in clinical operations, where continuously regulator-ready data becomes the foundation of future trial execution.
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Implementing Cognizant® Shared Investigator Platform: Lessons From The FieldOne leading oncology healthcare system and research institution has recently successfully implemented Cognizant SIP and shares its best practices around planning for and implementing Cognizant SIP given such a large footprint.
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EU Annex 11: How To Stay CompliantEU Annex 11 lays out the European Union’s regulations for using computerized systems during clinical trials. Learn how sponsors and sites seeking treatment approval in the EU must follow Annex 11.
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Clinical Trial Governance A Strategic Look At KPIs From An RTSM PerspectiveLearn how data-driven metrics improve oversight, mitigate risk, and accelerate execution while safeguarding supply continuity and patient safety.
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Flexible By Design: Support For Early-Phase Oncology TrialShifting cohorts, doses, and protocols challenge early-phase oncology trials. Learn how adaptable technology keeps studies on track.
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