Case Study

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

Source: Advarra
research Covid.jpg

IQVIA delivers world class site activation timelines, consistently achieving first patient/first visit performance for sponsors. The COVID-19 pandemic forced IQVIA to reimagine what was possible as it became clear traditional timelines would not be sufficient to move the new COVID vaccines through clinical trials and to the public at warp speed. As an added level of complexity, the research projects would involve a new class of vaccines involving genetically engineered compounds. U.S. NIH Office of Science Policy Guidelines on Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) and the requirement for institutional biosafety committee (IBC) review in addition to IRB would apply. A new level of collaboration between sponsor, CRO, sites, and oversight committees was needed to achieve desired results.

Because of the accelerated approval timeline for a COVID vaccine, IQVIA had to move fast. Sponsors expected approvals and turnaround times at warp speed without sacrificing safety, quality, and oversight so they could turn study data over to the Food and Drug Administration (FDA) as quickly as possible. IQVIA needed to work with an IRB and IBC partner who could accelerate review times so the COVID vaccine trial sites could progress through site selection, IRB/IBC submission, approval, drug shipment, and complete site initiation visits in record time.

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