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Coordination of Clinical Studies of Cell-Based Therapies
Multi-center clinical trials of autologous cell-based therapeutics require extensive upfront coordination of the BioLogistics of the collection and shipment of raw materials for manufacturing. Key Biologics has unmatched experience in supporting blood product collection for clinical studies for cell-based therapies and can manage all aspects of the process:
- Served as national coordinator for autologous whole blood collection for a phase IIb clinical trial of a therapeutic vaccine for multiple sclerosis and a follow-on open label trial of the vaccine
- Managed enrollment of subjects at 35 clinical sites across the U.S.
- Allowed sponsor to complete enrollment of targeted number of subjects (150) in less than 12 months
- Existing relationships with blood collection sites across the U.S. allow effective implementation of collections in a time- and cost-efficient manner
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