Article | September 8, 2022

How Are You Labeling Your IP? Protect Your Clinical Trial With Distinct Treatment Numbers

Source: Medrio

By Ian Davison, Ph.D. Neuroscience, Medrio’s RTSM Subject Matter Expert


Does your CRO or sponsor have a policy around IP numbering in clinical trials? If not, they could be putting your clinical trial at risk. Not numbering your IP may not seem like a problem, but that lack of identification and traceability could be critical in a safety situation or during reconciliation; it may even risk study blinding. Protect your clinical trial using Treatment Numbers as a standard practice.

Engaging randomization and trial supply management (RTSM) services early in study startup can help protect clinical trials and expose substantial efficiencies, effectively baking in practices that help streamline supply chains.

In a previous blog, Winning the Race to FPI with Early Randomization and Trial Supply Management – Medrio, we discussed the importance of your investigational product (IP) packaging on study success. However, how the product kits are labeled and whether they are numbered is just as critical to study efficiency. Deciding between labeling distinct units or shipping un-numbered units of investigational products can have significant implications for study outcomes.

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