eClinical Articles

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. Not What I Expected From A Vendor Conference 9/12/2024

   Dan Schell recounts some of his key takeaways after attending the Veeva R&D Quality Summit in Boston in September 2024. Some of the topics discussed include DCTs, eCOA, and the need to simplify tech integration at sites. 

6. KPIs To Consider When Evaluating Success With New Site Technology 8/22/2024

   Consultant Aurea Flores, Ph.D., offers specific advice for evaluating whether a new technology is embraced by site staff and fulfilling its purpose for the sponsor. 

7. Why We Need Technology Consolidation In Clinical Trials 8/16/2024

   As more and more trial designs incorporate technologies that generate an immense amount of data, data managers struggle to continuously interconnect disparate systems and standardize data. All of this fuels the need for technology consolidation.

8. A Quick & Easy Guide To Site-Facing Clinical Trial Technologies 8/15/2024

   Consultant Aurea Flores, Ph.D. summarizes some of the clinical trial technologies used by clinical research sites, their capabilities, and how sponsors and sites might best evaluate their use in clinical research.

9. ICH E6(R3) And Defining What Is Critical To TMF Quality 4/9/2024

   By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).

10. 3 Tips For Selecting Your eTMF Platform 3/7/2024

    Each eTMF platform presents its own set of advantages and drawbacks. Be sure to incorporate these three tips when considering a new eTMF vendor and its services.