Clinical Trial Compliance & Operations Tech Articles

1. 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.

2. 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. 

3. 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.

4. 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.

5. 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.

6. How To Turn Your Clinical Supply Chain Pandemic Learnings Into New Best Practices 3/10/2022

   Pivoting, navigating, and problem solving in real time during the pandemic has led to many real-time lessons that have evolved into adapted best practices in the global clinical supply space. This article discusses the new demand curve, packaging operations, IRT considerations, and more.