• The Key Differences Between Expanded Access Programs And Investigator Sponsored Trials

    Expanded access programs (EAPs) and investigator sponsored trials (ISTs) play significant roles. While both aim to provide patients with access to investigational therapies, they operate under distinct frameworks and serve different purposes. Understanding their differences from traditional clinical trials is crucial from an investigational medicine product and supply chain perspective.

  • Bayesian Adaptive Designs in Clinical Trials: Using Data Science To Optimize Investigational Product Supply

    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.

  • How To Create An Effective Clinical Supply Visual Dashboard

    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.

  • Clinical Trials: Envisioning A Future Where Technology Expedites Your Investigational Product’s Labeling & Shipment

    When you assess other industries and companies like Amazon, Tesla, and Coca Cola, each has a commanding use of innovation and technology to ensure they have what they need, when they need it, and that how it gets from pick-to-pack is swift and error-free. Some clinical trials operatives may say, “but they are not required to follow the GMPs” or “we work in a highly regulated industry.” To those, I say: that's an excuse. 

  • The 5 Pillars Of Clinical Trial Material Management

    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.


Christopher Ohms

Christopher Ohms is a San Francisco Bay Area native and serves as director of supply chain at Rigel Pharmaceuticals. Prior to joining Rigel, Ohms held positions at Gilead Sciences, Patheon, Stanford School of Medicine, Pain Therapeutics, and ALZA. His 27-year career in the medical and pharmaceutical settings has been in quality, project management, research, development, commercial operations, manufacturing, packaging and labeling, supply chain, sales and operations planning, and global clinical/commercial contracted relationships and oversight. Ohms has co-authored eight patents and holds a B.S. in biology and an M.A. in English literature.