Expert Insights On Data Management & Analysis

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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. 

  7. What Can Advanced Analytics Do For ClinOps? 9/18/2024

    Merck's Ed White and Randy Krauss discuss the implications of using advanced analytics to support clinical operations.

  8. 4 Steps To Help Sponsors Return Individual Patient Data 9/10/2024

    In part two of this series on individual patient data return (iPDR), Legacy Health Strategies experts offer four steps to help sponsors make iPDR a reality.

  9. Returning Individual Trial Data To Patients: How And Why It Needs To Happen 9/9/2024

    Returning individual data to clinical trial participants is seen by many as "the right thing to do." Yet, its uptake is lacking. Legacy Health Strategies experts discuss why it's so important and how it can be achieved in part one of this two-part series.

  10. Which Top HEOR Trends Will Have The Biggest Impact On Clinical Research? 9/6/2024

    ISPOR CEO Rob Abbott discusses Health Economics and Outcomes Research (HEOR) trends and how they're impacting clinical trials.