Expert Insights On Data Management & Analysis

  1. Breaking Down The FDA's Latest Guidance On Electronic Systems In Clinical Investigations 2/28/2025

    In October, the FDA took a significant step forward by releasing a new Q&A guidance clarifying the use of electronic systems, e-records, and e-signatures in clinical investigations.

  2. Are We On The Cusp Of A Quantum Revolution In Clinical Trials? 2/28/2025

    Though quantum computing is still in a nascent stage, life sciences companies are already investing in this technology to enhance predictive models, improve site selection, and find the right cohort.

  3. Tackling AI Copyright Challenges In Pharma And Clinical Research 2/21/2025

    Pistoia Alliance President Becky Upton, Ph.D. explains pharma and clinical research organizations must collaborate to address copyright and data-sharing challenges with or AI — or risk stalling innovation.

  4. A Tool To Tackle The Risk Of Uninformative Trials 1/31/2025

    Uninformative trials hinder progress in clinical practice, policy decisions, and further research. Fast Data Science developed a free risk tool to help pharma companies avoid them.

  5. Using Critical To Quality (CtQ) Factors To Identify The Critical Data For RBQM 1/2/2025

    Based on ICH E8(R1) quality by design (QbD) principles, experts explain the use of critical to quality (CtQ) factors to identify critical data that focuses the end-to-end RBQM process on patient safety and trial results.

  6. 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.

  7. 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.

  8. 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.

  9. Leveraging RWD With AI To Enable Diverse Recruitment In Clinical Trials 12/11/2024

    A diverse cohort of clinical research participants is vital to developing studies that are representative of the target population. Real-world data (RWD) can be paired with AI to integrate unstructured data.

  10. 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?”