CRO Leverages Partnership With Integrated Central IBC To Initiate Sites In COVID-19 Vaccine Research At Warp Speed

A prominent Contract Research Organization (CRO) renowned for its exceptional expertise in expediting site activation and achieving the remarkable milestone of first patient/first visit performance for its sponsors found itself facing an unprecedented challenge when the COVID-19 pandemic hit. It became evident that adhering to traditional timelines would be insufficient to expedite the clinical trials of the new COVID-19 vaccines and swiftly make them available to the public.

Adding to the complexity of the situation, these research projects involved a novel category of vaccines incorporating genetically engineered compounds. This novel territory required strict adherence to the U.S. NIH Office of Science Policy Guidelines on Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) and necessitated institutional biosafety committee (IBC) reviews in addition to the customary Institutional Review Board (IRB) oversight.

To attain the desired outcomes, a heightened level of collaboration between the sponsor, CRO, clinical sites, and oversight committees was indispensable. Delve into the results of this solution by downloading the case study below.