When Temperature Compliance Is Non-Negotiable, CSM Relies On CredoSource: Minnesota Thermal Science, LLC
Based in Fargo North Dakota, CSM is a full service packaging and labeling company that specializes in supplying investigational medicines, including cancer drugs and supplies for clinical trials. CSM’s licensed pharmacists and pharmacy technicians work with a number of large pharmaceutical and biotech companies, hospitals and contract research organizations in the U.S. and around the globe.
The pharmaceutical and biotech companies that sponsor adaptive trials work in compliance with FDA requirements to identify criteria for each study. As studies evolve, patients with particular characteristics are removed, while others are added. Many of the drugs in these trials are being used for the first time ever, so change is a continual part of the process, which usually requires large amounts of excess inventory.
According to CSM’s Director of Operations Bob Albanese, a highly flexible, on-demand packaging and labeling process is the only way to support these kinds of adaptive trials. “Because in many cases we’re shipping out the first batch of a new drug that’s ever been produced, we have to plan for a variety of change-requests to the dosages and combinations that we prepare for each patient.”