Expert Insights On Data Management & Analysis

31. What Future Laboratory Manuals Should Look Like 12/20/2024

    In the final article of this series on lab manuals, FlexPoint Bio Founder and CEO Elena Sinclair imagines what the perfect lab manual might look like — and how to make it a reality.

32. How Laboratory Manuals Fail Sites And Sponsors 12/19/2024

    In part one of this series, FlexPoint Bio Founder and CEO Elena Sinclair describes the hazards of poorly designed (and followed) clinical trial lab manuals.

33. Lab Manual Gaps: Sabotaging Data One Sample At A Time 12/19/2024

    In part two of this series on lab manuals, FlexPoint Bio Founder and CEO Elena Sinclair discusses the criticality of sample and process quality.

34. How Did Clinical Researchers Actually Use AI In 2024? 12/5/2024

    Looking ahead to 2025, Clinical Leader seeks to understand how clinical research professionals are incorporating AI into their work. So we asked them, “Simply put: Are you using any iteration of AI in your role within clinical research? If so, how and why?”

35. Pondering The "What Ifs" Of Inspection Readiness With Generative AI 12/4/2024

    Just In Time GCP Founder and CEO Donna Dorozinsky contemplates some of the developing uses of generative AI for inspection readiness.

36. A Data-Driven Approach That Could Change Mental Healthcare In 2025… And Beyond 12/2/2024

    Heterogeneity of patient populations combined with subjective clinical interpretation often results in imprecise treatments, frustrated patients, and poor outcomes, says Greg Hajcak, Ph.D. Here, he argues for a data-driven approach, also called “precision psychiatry,” to personalize clinical trials and care.

37. Seeing Firsthand The Transformative Impact Of AI On Pharmacovigilance And Clinical Research 11/27/2024

    Consultants Aashna Goyal and Guriqbal Singh share first-persona accounts of how AI is transforming pharmacovigilance and clinical research by improving data processing, enhancing decision-making, and accelerating drug development.

38. Alexion Rethinks Diversity Metrics And Why Race Alone Isn't Enough 11/8/2024

    Clinical research does not adequately measure diversity, argues Alexion's Adrian Kielhorn. An expert in health economics and outcomes research (HEOR), Kielhorn suggests a more nuanced way of looking at diversity.

39. AI's Potential Must Reconcile With R&D And Regulatory Bottlenecks 10/11/2024

    Evaluate's Daniel Chancellor explains that by working together to expand AI resources and adapt regulatory frameworks, the FDA and others can ensure the benefits of AI are fully realized while maintaining high standards of safety and efficacy.

40. Massive Data, More Decentralization Drive Updates To ISPE GAMP Guide 10/4/2024

    ISPE GAMP Guide lead author Frank Henrichmann describes the changing clinical data environment and details updates that will support the work of various clinical trial stakeholders.