The clinical research team includes two physicians who are board-certified in transfusion medicine and a PhD-level director with extensive clinical trial experience.
In total, the team has more than 50 years of combined experience as principal investigators of investigator-initiated and industry-sponsored, IRB-approved protocols. The organization has participated in more than 50 studies with protocols encompassing blood product collection and characterization, and device and assay performance assessments for regulatory approval.
The clinical research team supports population screening, blood technology industries, and NIH biomedical research programs.
Our CITI-trained staff are experienced in pre-clinical and all phases of clinical trial support and includes a clinical research manager, coordinators, recruiters and phlebotomists.
The team has a growing research donor registry of more than 35,000 discrete registrants managed in a secure clinical trial management system. Donors are recruited for specific criteria from the well-characterized registry.
After completion of a research informed consent, the team implements custom screening requirements including on-site testing and physical examination in private screening rooms. At a dedicated collection space, research subjects donate under IRB-approved protocols.
A pharmaceutical company developed an autologous immunotherapy for treatment of cancer using a patient’s own immune cells. Partner sites were required to collect the patient’s mononuclear cells through apheresis and ship for further manufacturing into the immunotherapy.
To support the clinical trial, the BioBridge Global:
Since this immunotherapy received FDA approval, we have maintained the partnership and continue to provide apheresis collections to support this commercialized therapy for patients in South Texas. The organization collaborated in the creation of a tool for other apheresis centers to improve and enhance collections.
