It’s Time for GS1 Standards in Clinical Research

As pharmaceutical companies continue to research new treatments, the number of clinical trials is growing dramatically. This has brought a problem that has long plagued the pharmaceutical research industry to the fore: a lack of standardized barcodes when it comes to investigational products.

Pharmaceutical sponsors tend to identify and name their investigational products on an individual basis, serializing and barcoding them without using a common method. This poses a challenge to research pharmacies like Dana-Farber, who must then manage hundreds of studies across several pharmaceutical sponsors, all with their own labeling and packaging systems. This leads to a lot of inefficiency when it comes to internal inventory tracking.

Developing Better Treatments More Efficiently

Several of the world’s top pharmaceutical firms are advocating for the implementation of standardized barcodes in investigational products. They are pushing for the use of global GS1 standards for identifying products and sharing information within the clinical research ecosystem because standardization will help their processes become a lot more efficient.

This is particularly important in light of the trend toward personalized medicine and recent developments in mapping the human genome and newly discovered molecular targets. While the result could be treatments that are more effective, the clinical research ecosystem needs to be able to keep up. Clinical sites currently spend a lot of time receiving and dispensing products.

GS1 Standards can bring some consistency to identifying investigational products and help boost innovation. Right now, the big pharmaceutical companies typically support hundreds of research studies at a time across dozens of countries. This involves tens of thousands of investigational sites as well as patients numbering in the hundreds of thousands. In fact, just one late-phase study could involve more than a thousand researchers. Given the tremendous scope of these studies, standardized procedures for investigation could help to automate manual processes and avoid problems like transcription errors and time-consuming verification and validation.

This blog post was based off of an article from Applied Clinical Trials. View the original here.





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