Featured Editorial

1. The Risks Of AI In Clinical Research From A Trial Management Perspective 4/9/2025

   In part two of this series, consultant Donatella Ballerini explores the challenges of integrating AI into eTMF management and how to mitigate them.

2. How AI Models Can Actually Improve eTMF Management 4/8/2025

   GCP consultant Donatella Ballerini explores how AI is shaping eTMF management and what this means for the future of clinical research in part one of this series.

3. eClinical Solutions Market To Double In 5 Years, As Sponsors Prioritize Efficiency 4/4/2025

   The global eClinical solutions market is projected to reach $22.1 million in 2029, double its presence in 2024. Experts discuss the specific solutions driving market growth and share how they impact clinical operations.

4. 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.

5. Why Is Trust Stifling Our RBM Implementations? 3/6/2025

   It’s one thing to implement RBM (risk-based monitoring) components like central monitoring or initial risk assessments, but if you’re still doing 100% SDR/SDV, you’re not maximizing the benefits of this approach. So what’s the holdup?

6. Pros & Cons Of Using Wearables In Clinical Trials 2/26/2025

   What are the biggest advantages and challenges of using wearables in a clinical trial? And who do you need on your team to add wearables to a trial? These are the questions Bryan Hansen, Ph.D. of Johnson & Johnson Innovative Medicine answers in this Q&A.

7. Wearables: An Essential For Decentralized Clinical Trials 2/20/2025

   Bryan Hansen, Ph.D., director of Innovative Health at Johnson & Johnson Innovative Medicine, discusses types of wearables, his experience using them in neurological disease clinical trials, and some future plans for these devices.

8. Bring-Your-Own-Device For eCOA — Is It Worth It? 2/19/2025

   At the recent SCOPE Summit, four experts in data management, monitoring, site operations, and tech weighed the pros and cons of adopting bring-your-own-device (BYOD) requirements for clinical trial eCOAs.

9. Input Needed On Using AI To Create Lay Summaries Of Trial Results 2/7/2025

   CISCRP is soliciting feedback from research professionals, patients, and advocacy groups on its "Considerations for Using AI to Create Lay Summaries of Trial Results" until Feb. 18.

10. Strategizing And Implementing Your Clinical Trial Technologies 1/23/2025

    An implementation strategy will help you overcome challenges in integrating tech such as electronic clinical outcome assessments, electronic patient reported outcomes, and digital health technologies.