Clinical Trial Compliance & Operations Tech Articles

1. 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.

2. 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.

3. 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?

4. 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. 

5. 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. 

6. 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.

7. Could GenAI Dramatically Reduce The Cost Of Regulatory Medical Writing? 7/3/2024

   Time-poor regulatory professionals stand to benefit substantially from generative AI, which can speed up the creation of marketing authorization applications or life cycle maintenance activities, for example. However, success will depend on how the technology is applied and controlled.

8. Enhancing Clinical Trial Efficiency & Compliance With eQMS 1/10/2024

   In recent years, electronic quality management systems (eQMS) have emerged as powerful tools to streamline and enhance the quality control processes in clinical trials. This article explores the key components, benefits, challenges, and future of eQMS in the context of clinical trials.

9. RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3) 9/12/2023

   Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts survey contributor, discusses the findings of the groups’ joint global research study with CluePoints and Price Waterhouse Cooper (PwC), the implications of the upcoming ICH E6(R3) guidelines, and the future of risk-based clinical trial conduct. 

10. How To Accelerate Digital Clinical Transformation Through A Holistic Approach 8/31/2023

    Only one third of companies that have started a digital transformation journey has witnessed the expected ROI/revenue benefits. In the successful cases, a holistic, integrated approach created the transformational value. Explore the 10 key enterprise capabilities for successful digital clinical transformation.