Guidance on the considerations for Pharmacy Clinical Trial Sites outsourcing activities involved in the delivery of ATIMPs


Delivery of Advanced Therapy Investigational Medicinal Products (ATIMPs) is becoming more widespread as interest in these innovative medicines increases.  Sites may not have access to the specialist expertise, knowledge or equipment required to suitably store or prepare ATIMPs, so may need to outsource aspects of their handling in order to ensure patients have access to these trials.


This guidance describes the legal basis for associated activity and provides guidance for Pharmacy clinical trial sites who may need to outsource these services.  The information provided will guide Pharmacy trial sites in establishing appropriate partnerships and understand the regulatory position with regard to the activities contracted.


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