Improving Clinical Supply Chain Management by Establishing End-to-End Visibility
Emerging pharmaceutical companies frequently place responsibility for clinical supply chain management on their clinical operations team and CROs. This approach can work initially for small, resource-constrained organizations. However, it does not help companies build the internal capabilities, knowledge, and resources to successfully run their clinical supply chain over time as they grow. One client developing enzyme-based therapies was conducting a randomized and blinded pivotal Phase III clinical trial. Along the way, testing parameters changed as they prepared to expand the trial footprint. The changes could increase the supply requirements. Since an additional manufacturing run would be a multimillion-dollar investment, the company wanted confirmation that another run was truly necessary. The internal resource charged with supply planning was part of the Clinical Operations team. Due to the individual’s clinical operations responsibilities, they were blinded to maintain the integrity of the study. However, to truly examine the demand/supply dynamics and assess manufacturing requirements, access to unblinded data was necessary. Management engaged Converge to analyze the demand/supply situation, prioritize supply issues and resolutions, and proactively manage clinical supply chain activity.
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