Case Study

Meridian Builds Robust Gene Therapy Research Program By Leveraging Advarra IBC Services

Source: Advarra
iStock-852590864-gene-lab

Meridian Clinical Research stepped into a new phase of their multi-site clinical trials program by taking on studies involving genetically engineered vaccines. They wanted to ensure the program’s success from the start by choosing Advarra as their strategic partner as such trials require review and oversite by both an Institutional Review Board (IRB) and an Institutional Biosafety Committee (IBC). Eight of Meridian’s sites utilized Advarra’s central IRB and IBC to ensure the safety of trial participants, as well as site staff when conducting gene therapy research. Having never worked with an IBC before, Meridian wanted to partner with an IBC to ensure their sites’ processes and workflows were efficient and compliant. Their staff received training on IBC requirements and submissions as well as a dedicated point of contact for questions.

Partnering with Advarra’s Institutional Biosafety Committee, Meridian Clinical Research established a program for conducting clinical trials with cutting edge, genetically engineered vaccines. Eight sites worked off of harmonized standard operating procedures (SOPs), resulting in an average four-day turnaround time for approvals. As a result of Meridian’s comprehensive and robust program, they were among the first sites to obtain approval for a large  Phase III COVID-19 vaccine study under Operation Warp Speed (OWS).

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