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Nationwide BioLogistics Management
LBS' Nationwide BioLogistics Management services offer critical support throughout all phases of clinical studies of autologous cell-based therapies. LBS coordinates collections of autologous raw material across the U.S. for cell therapy manufacturers through its Cell Collection Networksm. 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. With Nationwide BioLogistics Management, we can:
- Identify potential options for blood product collection in metropolitan areas in which subjects will be enrollment into a study, prior to initiation of subject enrollment at the study site
- Qualify potential collection sites based on demonstrated experience, expertise, capacity, capability, and willingness to participate, prior to initiation of subject enrollment at the associated study site
- Train collection staff at qualified sites on study procedures, prior to first subject visit to the collection site
- Prescreen subjects for eligibility for collection using Internet-based, FDA-approved health history questionnaire
- Educate subjects about the collection procedure
- Coordinate collection of samples for pre-collection laboratory studies and coordinate performance of testing, as needed
- Coordinate any needed pre-collection visit to collection site by subject
- Schedule collection date and time with subject, collection site, sponsor and manufacturing site
- Ship and confirm delivery at the collection site of materials needed for labeling, packaging, and shipment of collected product to manufacturing site in accordance with sponsor and manufacturer’s specifications
- Confirm arrival of subject at site on date of planned collection
- Confirm successful collection, packaging, and pickup of product at collection site
- Confirm receipt of product at manufacturing site
- Coordinate post-collection assessment of subject, as needed
- Receive and pay invoices for all services from collection site
- Collect, collate, and maintain records associated with apheresis collections, as warranted
- Invoice sponsor monthly for services provided
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