Contract Collection & Biologistics^sm Management

Multi-center clinical trials of autologous cell-based therapeutics, require extensive upfront coordination of subject screening, collection, packing and shipment of raw materials for manufacturing and of their subsequent return to a site for administration of the finished product to trial participants. Key has unmatched experience in managing all aspects of cell and blood product collection for clinical studies involving cellular therapies. Key refers to these coordination services as BioLogistics^sm.

Key serves as a CCMO (contract collection management organization) providing critical BioLogistics^sm support throughout all phases of clinical studies of autologous cell-based therapies.

Key works in a supportive, but critical, capacity when patients are sourced from participating clinical trial sites. In these circumstances when collection services specified by the sponsor are not available at the investigator site, Key works through its Cell Collection Network^sm, a group of regional blood centers and other biological product collection facilities that have been qualified to serve as collection sites for such studies.

This service eliminates the need for the manufacturer to develop an in-house function for coordinating subject/patient screening and scheduling, as well as product collection and shipment for manufacturing. Key’s role is typically focused around assuring the collection of the desired biomaterials from the patient in a manner that strictly adheres to the protocol requirements.