Expert Insights On Data Management & Analysis

  1. Multiple Partnerships Help Drive Precision Medicine Trial For Parkinson's 3/31/2025

    Neuron23 CMO Sam Jackson, MD, explains the company’s desire to set a new standard in precision medicine for neurology, backed by well-aligned partnerships and fit-for-purpose digital biomarker solutions. 

  2. If Patients Want A Better Quality Of Life, Why Isn't That A Focus For Pharma? 3/25/2025

    Medical oncologist Frédéric Fiteni, Ph.D. reveals the widespread industry reluctance to study patient quality of life, describes its importance to patient satisfaction, and offers best practices for its integration.

  3. A Decade Of Data Sharing: Insights From J&J And Yale's YODA Project 3/12/2025

    Joseph S. Ross, MD, MHS, and Karla Childers, MS reflect on a decade of data sharing and the lasting impact of the Yale University Open Data Access (YODA) Project on clinical research. 

  4. Tired Of Manually Reviewing Disparate Data? Try Integrated Data Review 3/11/2025

    Integrated Data Review (IDR) has emerged to offer a unified, real-time approach to managing clinical trial data by consolidating diverse datasets on a single platform. 

  5. Is Double Programming Really Required For Validation? 3/10/2025

    Double programming has been the gold standard for validation, but technological advancements and improved sponsor oversight of CRO deliverables have introduced more efficient and reliable alternatives.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.