Clinical trials: exploring a new frontier for GS1 standards in healthcare

For the first time as part of a GS1 Healthcare Conference, there was a global discussion about the potential role of GS1 standards in clinical trial processes.

Representatives from the Alliance for Clinical Research Excellence and Safety (ACRES), U.S., Pfizer U.S., Sanofi, France, and the Dana-Faber Cancer Institute, U.S., shared their vision for the future use of GS1 standards in the identification of investigational products.

Developing an innovative medicine is a lengthy and complex process. Dr. Greg Koski, CEO of the Alliance for Clinical Research Excellence and Safety (ACRES), described the complexity of clinical trial processes and ACRES’ objective to help drive connectivity, interoperability and synergy in this environment.

Clinical research organisations such as the one at the Dana-Farber Cancer Institute face the challenge of managing hundreds of studies across multiple pharmaceutical sponsors, each with its own unique packaging and labelling.

Sylvia Bartel, Vice President of Pharmacy at Dana-Farber advised that the industry needs global standards for investigational products used in clinical trials. She highlighted the differences in the readability of investigational product labels compared to the labels of manufacturers’ commercial products and the resulting challenges such as transcription errors and manual receiving processes. Representing pharmaceutical sponsors of clinical trials, Hans von Seiger, PMP Group Leader, Clinical Supply Management with Pfizer and Sylvain Alberola, Head, Clinical Supply Chain Industrial Development, Sanofi, presented their vision and commitment to implementing GS1 standards for clinical trial processes.
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