Coordination of Patient-Donor Cellular Collections

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.

For investigator sourced patients, Key offers several options:

• Serves as a collection site to which investigators refer their patients for the specialized cell collection procedures called for in the protocol.

• Identifies, qualifies and contracts for the services of other collection sites outside of Key’s Memphis service area, either drawing on the capabilities of the Cell Collection Network^sm or a service provider in the local area. An important aspect of identifying and qualifying collection sites is assessing the site’s ability to serve patients who differ from the population which that site is accustomed to serving. For example, threshold questions used to qualify prospective collection sites include, Can the site accommodate sick or frail patients or patients with limited time? Does the site have the requisite equipment? Is the site staffed to counsel the patient on the procedure, to conduct the procedure and to complete the case report form?

• Provides fully trained personnel and related equipment to perform cell collections in the investigator site. This collection venue tends to be more expensive than referral to a qualified collection site. However, sometimes the use of traveling collectors is necessary to keep the trial on its timetable.