Critical decisions are taken during protocol design. It is essential to maintain patient centricity and respect site constraints, but it is also an opportunity to evaluate the supply impact. Different scenarios can be investigated with an advanced simulation and optimization tool that accurately models both the clinical design and the supply aspects of the protocol. […]read more
Pharmaceutical organizations are putting more and more pressure on clinical supply chain managers to minimize study overage. Study overage represents the kits that will expire unused at the investigational sites, local depots and central depot. Some overage is absolutely needed, both as insurance against the unexpected events that can occur during the trial and as a result of the design of the protocol and distribution network.
But often the question is raised (and not only by higher management): is the requested amount of overage absolutely necessary or is it possible to decrease it?
Clinical trial supply overage – How to reduce product wastage while keeping a perfect service level for patients?
For decades, risk in clinical trial supply has been mitigated by maintaining buffers of drug available throughout the supply chain. Buffers are necessary to cover the inherent variability in the demand of clinical trials. When not consumed by patients during the trial, these buffers result in unused drug, or “overage”. When investigational medicines are readily available and not expensive, having higher overage in a study can be accepted by the company in order to ensure no risk to patient service level.read more