BBG Advanced Therapies collects first cell donation on one-of-a-kind bus

Clinical Research Support

The clinical research team includes two physicians who are board-certified in transfusion medicine 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 custom blood and biospecimen collections from healthy participants and populations with known conditions, 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.

Clinical Research

The team has a growing research donor registry of more than 50,000 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.

BioBridge Global Clinical Research Support Donor Registry
 
  • Established protocols overseen by a central IRB
  • Implementation of sponsor’s protocols by request
  • Controlled Human Subjects Research policies and procedures
  • Quality management system and electronic batch records
  • FDA submission support
  • Expedited process for contracting and study start-up
Clinical Research

From 2022 to 2025, BioBridge Global was a trusted site for a large, nationwide NIH funded study, the All of Us Research Program.

To support this study, BioBridge Global:

  • Built numerous trusted community partnerships with local organizations to promote program education and enrollment
  • Served as a recruiting and biosample collection site
  • Collected biosamples (including blood & urine) from ~650 participants
  • Developed and implemented a mobile biospecimen collection program
  • Supported NIH longitudinal research

The All of Us Research Program aligned closely with our mission to advance science to serve diverse communities and address disparities in healthcare access and outcomes. The program has and will continue to make biomedical research more equitable and representative for all.

Note: In 2025, the funding for this program was greatly reduced, resulting in the program closing all of the blood center partner sites (including the BioBridge site).

The program and the mission of the All of Us Research program continues on. Learn more here: All of Us Research Program.

Clinical Research

Case Study

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:

  • Qualified as an apheresis collection site for the clinical trial
  • Developed partnerships and communication plans with local hematology/oncology physicians
  • Developed all internal SOPs in accordance with the company’s protocol, in a cGMP compliant manner
  • Reported on clinical trial activity and performed electronic data entry as required by the sponsor to support their FDA submissions

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.

Clinical Research
BioBridge Global Research and Development
Commitment to Quality
Quality has been a guiding principle within our organization for almost 50 years.
Contact Us
For additional information about our products and services.
Certifications
View list of U.S. and international accreditations, certifications and registrations.