Investigational Medicinal Product Management
The importation and distribution to clinical sites of an IMP manufactured inside or outside the European Union presents a significant logistical challenge. Actually, the challenge already starts with the requirements for the labeling in the different European countries. It is a legal requirement that an IMP manufactured outside Europe be released into Europe by a European Qualified Person (QP) before it is distributed to the relevant clinical sites. Kinesis Pharma provides services to facilitate and manage IMPs for clinical trials in the EU e.g. arranging for QP release and managing the sponsor’s relationship with the QP, label and packaging (subject kits) and shipment to clinical sites.