Expert Insights On Data Management & Analysis
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How AI And Secondary Data Use Are Changing The Way We Do CTAs, Part Two
5/19/2025
Leibowitz Law experts examine how tech developments affect key CTA provisions and provide practical, technology-inspired updates for your clinical trial agreements. Part two covers the secondary use of study data and AI.
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How Recursion Is Industrializing Clinical Trials With AI
5/12/2025
Recursion SVP of Clinical Development and Data Science Sid Jain discusses the company's three-point "ClinTech" strategy, focusing on AI-assisted trial design, trial execution, and evidence generation.
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Caregiver Distress: The Hidden Burden Of Dementia With Lewy Bodies — And Why Measuring It Matters
5/7/2025
Taking care of a loved one can be challenging. Cognition Therapeutic experts contend that caregivers’ distress levels must be evaluated to better understand the impact of dementia with Lewy bodies (DLB) on patients, families, and society.
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Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis
5/5/2025
Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.
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The Evolving Landscape Of Data Integrity In Good Clinical Practice
4/30/2025
ERA Sciences Andy O'Connor explores the growing focus on data integrity in good clinical practice (GCP) and how regulatory guidance is evolving to support a risk-based, system-life cycle approach.
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Unsure About The New ICH Guidelines? TransCelerate Debuts 13 Tools To Help
4/23/2025
TransCelerate BioPharma's Tashan Mistree discusses 13 new tools created alongside the Association of Clinical Research Organizations (ACRO) to support ICH GCP E6(R3) adoption.
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Data Overload: Determining Which Trial Data To Collect
4/11/2025
Clinical trials collect a substantial amount of participant data, but not all of it is necessary. Learn how to decide what data's needed and what's not.
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The Risks Of AI In Clinical Research From A Trial Management Perspective
4/9/2025
In part two of this series, consultant Donatella Ballerini explores the challenges of integrating AI into eTMF management and how to mitigate them.
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How AI Models Can Actually Improve eTMF Management
4/8/2025
GCP consultant Donatella Ballerini explores how AI is shaping eTMF management and what this means for the future of clinical research in part one of this series.
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Struggling With GxP Systems? There's A DAP For That
4/2/2025
A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.