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 investigator 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, device and assay performance assessments for FDA approval.
The CITI-trained clinical research team is 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 30,000 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.
Regulatory:
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 organization:
Since this immunotherapy received FDA approval, South Texas Blood & Tissue has maintained its partnership and continues 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.
