Downloads
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Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
5/19/2026
FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.
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QA Transitions Don't Create Inspection Risk — They Reveal It
5/19/2026
Consultant Wijdan Suliman, MD, MHA, explains how QA leadership changes can reveal risks, including differences in the interpretation, lost historical context, and more.
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A Digital Health Solution For Continuous, Long-Term Cough Monitoring
5/15/2026
The way we measure respiratory symptoms is changing. Explore the effects of combining AI-powered cough detection with wearable digital health technology for continuous, long-term cough monitoring
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Optimizing Wearable Adherence In A Phase 3 Oncology Trial
5/15/2026
Long-term wearable monitoring only works if patients keep wearing the device, and in oncology trials, that’s easier said than done.
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Contracting For AI In Clinical Trials: Cybersecurity, Monitoring, And Risk Allocation (Part 3)
5/15/2026
Leibowitz Law shares the third installment of its three-part series on contracting for AI in clinical trial operations. Part 3 picks up with cybersecurity, monitoring and validation, and risk allocation.
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Contracting For AI In Clinical Trials: Data Rights And Regulatory Compliance (Part 2)
5/15/2026
Leibowitz Law's three-part series examines how AI is being used in clinical trial operations and the contractual and operational risks that follow. Part 2 demonstrates why organizations must understand where it is used, how it interacts with data, and where the risks lie.
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Where AI Appears In Clinical Trials — And Why Contracts Need To Catch Up (Part 1)
5/15/2026
Leibowitz Law's three-part series examines how AI is being used in clinical trial operations and the contractual and operational risks that follow. Part 1 outlines where AI appears in ClinOps and supporting technologies, and the questions companies and organizations should ask when AI touches data.
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Designing Trials Patients Can Actually Complete: Lessons From The SWIFT Deep TMS Study
5/15/2026
Being time conscious and attuned to patient needs are two contributing factors to trials that recruit and retain patients for the duration.
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AI Meets Informed Consent: Opportunity, Risk, and What IRBs Need to See
5/14/2026
Expert perspectives on IRB oversight, health literacy, and research ethics offer practical guidance to strengthen consent, protect participants, and align compliance with real-world research.
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It's A Fact: Sharing Clinical Trial Results With Participants Builds Trust
5/14/2026
CISCRP experts share results from their annual Perceptions & Insights Study showing that patients continue to place a high value on receiving both individual and overall study results.