ARTICLES BY CHRISTOPHER OHMS

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

  3/6/2024

  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

  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.

• 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.

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

  10/14/2021

  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

  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.