Clinical Guest Contributors

  1. Solving The Protocol Deviation Puzzle With FDA Draft Guidance 3/14/2025

    Knowing exactly what to do when a protocol deviation (PD) arises can be challenging. Here, consultant Leila Cupersmith summarizes new FDA guidance on managing PDs.

  2. Invest In This One Thing To Help Strengthen Your ClinOps Team 3/13/2025

    As clinical research faces unprecedented transformation in trial conduct, sponsor companies that will survive — and thrive — are the ones investing in their people.

  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. Social Media And A Site-Less Model Led This Trial To Pandemic-Era Success 3/10/2025

    Genescopy's Chief Science and Medical Officer Erica Barnell, MD, Ph.D. explains how social media recruiting and a site-less trial design helped the company's CRC-PREVENT Phase 3 trial succeed.

  6. 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.

  7. Trends In FDA FY 2024 Inspection-Based Warning Letters 3/7/2025

    Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.

  8. Bridging Clinical Research And Care With TransCelerate's Rob DiCicco 3/7/2025

    TransCelerate's Rob DiCicco offers insights into why bridging clinical care and research matters and the challenges that must be overcome to realize the vision.

  9. Combination Products: U.S. Vs. EU Requirements And A Harmonized Strategy To Prepare CTD Module 3 3/6/2025

    In the U.S. and the EU, there are differences in the terminology used for combination products, as well as in the format and location of the information in the dossiers. This article also proposes a harmonized approach for CTD Module 3.

  10. Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies' 3/5/2025

    The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.