Clinical Supply Management Articles

  1. How To Speed Up Time To Market With CMC Knowledge Management 1/24/2024

    Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.

  2. Bayesian Adaptive Designs in Clinical Trials: Using Data Science To Optimize Investigational Product Supply 11/30/2023

    While it is challenging to make precise predictions for clinical trial supplies, applying Bayesian statistics will help. This article shares steps to plan your Bayesian approach and how it helps to reduce waste and prevent shortages.

  3. 7 Improvements in Clinical Supply Chain Management Your CFO Will Love 10/2/2023

    There is a great opportunity for clinical supply chain practitioners to learn from their commercial peers. By adapting and adopting the right commercial best practices, clinical supply chains become more effective, cost-efficient, and agile in delivering the right treatments to the right patients.

  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.

  7. How AstraZeneca's Clinical Trials Procurement Team Adapted To The Pandemic's Demands 10/7/2021

    The pandemic has tested AstraZeneca’s Global Operations organization to ensure clinical trials continue. As a function, procurement plays a key role across this supply chain, with a strong emphasis on assuring supply of product on time and with solid service by third-party suppliers to respond to any shifts in demand. Here's how AstraZeneca's procurement team successfully adapted.

  8. The 5 Pillars Of Clinical Trial Material Management 2/25/2020

    Ensuring that enough study drug supplies are available at study sites is a requirement of every clinical trial. This article discusses five fundamental tools and techniques for effective planning, execution, monitoring, and inventory control of clinical trial material from the manufacturing, packaging, and distribution perspectives.