The need for Global Standards
in the Clinical Trial Supply Chain


July 2020

Clinical trials processes have complexities not seen elsewhere

Global standards are used for identification of commercial pharmaceutical products, making it possible to increase traceability of drugs and ensure patient safety in the most efficient way. The same approach to identification has not yet been taken in the clinical trial supply chain, although clinical trials deal with severe identification complexities:

For example, the uniqueness of an investigational product, which in many cases is only for a single patient, means that it must be identified down to the instance of the product. And in blinded trials the investigational product, comparator or placebo, must not be differentiated from each other.

The burning platform for security

“Pharmaceutical companies sponsor tens of thousands of ongoing clinical trials, conducted by investigators ranging from the largest research institutions to solitary practitioners. With the current trend of more and more treatment changes from mass produced pharmaceuticals to personalized medicines, the number of clinical trials can be expected to increase in the future – and therefore so will the need for bullet proof identification”, believe Marianne Puggaard Jensen, Educational Programme Leader in Atrium.

Therefore, GS1 Denmark and Atrium have developed an introductory course in “New Standards for Investigational Medicinal Products (IMP) in Clinical Trials”, targeted at all pharma professionals involved in clinical trials.
“Clinical trial sponsors continuously search for ways to make research processes simpler and more efficient. Implementation of global GS1 standards for identification and labelling of all investigational products is a tool to achieve that. All we need now is to educate stakeholders on how to go about implementing standards in their processes. This is what the course provides an introduction to”, explains Jesper Kervin, Head of Healthcare Sector at GS1 Denmark and course leader for “New Standards for Investigational Medicinal Products (IMP) in Clinical Trials”.

Master optimization of processes via standards

Research pharmacies face the challenge of managing hundreds of trials across multiple pharmaceutical sponsors. Today, each pharmaceutical sponsor identifies and names their investigational products in different ways, each with its own unique packaging and labeling. Because of this lack of standardization, research pharmacies commonly have to re-label packages to manage investigational products, which is an expensive and potentially error prone process.

Standardizing approaches for identifying investigational products. For example, a trial site only needs ONE process, instead of many, to handle investigational products from multiple manufacturers. Similarly, a manufacturer only needs to generate ONE barcode on an investigational package making it simpler for trial site users. Contrast this with the current process where receiving products into trial sites in the absence of standardized identifiers and barcodes involves expensive and potentially error prone manual processes.