Clinical Trial Compliance & Operations Tech Articles

  1. 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?

  2. 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. 

  3. 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. 

  4. 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.

  5. 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.

  6. 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.

  7. 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. 

  8. 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.

  9. EU Reg. 536/2014's Expiry Label Requirement Forces Us Backward, Not Forward 9/14/2022

    In a world shifting toward advanced technology, the new EU Regulation No. 536/2014's Annex VI is forcing us back into the paper age; specifically, the new requirement to print the expiry date on the primary container label, not just the external carton label. This article describes what is now required, how we got here, and how we can move the industry forward.

  10. How To Create An Effective Clinical Supply Visual Dashboard 4/5/2022

    It is challenging to keep track of inventory positions at clinical sites, depots, and clinical packaging organizations. Randomization and trial supply management (RTSM) systems do not encapsulate all the necessary data. It is vital to have an internal central inventory system that maintains oversight of the IP inventory from start to finish and to manage resupplies.