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Case Study # 5: The Pharmaceutical Cold Chain

Given the sensitivity around a new drug or formulation, clients in the West pursue a process wherein the drug reaches each site directly from the manufacturer. On the contrary, we recommend all investigational products be shipped to a central research pharmacy (managed by TMI) in India, from where the requisite drugs are individually shipped to each site based on requirements.

An investigational product was required to be maintained at -20o C until 24 hours prior to usage. By ensuring that the Investigational Product arrived in India to a central pharmacy and thereby being dispensed as per site requirements, the integrity of the cold chain was maintained. The alternate option of the drug being shipped from the western facility directly to the sites results in a serious breakdown of cold chain continuity and hence, viability of the product. This is a reflection of the nuances in India that the sponsor is not always aware about. TMI understands similar local issues and takes on the local responsibilities to ensure that all components of the trial are achieved.