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IQVIA

COVID-19 prompted close working relationship with IRB, IRC provider says IQVIA

Posted by on 28 June 2021
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IQVIA says its novel partnership with Advarra helped it meet COVID-19 vaccine and therapeutic developers’ demands for shorter timelines.

The CRO shared details of its collaboration with the institutional review board (IRB) and institutional biosafety committee (IBC) services firm this month, explaining that sponsors demand for faster clinical processes was the prompt for the accord.

“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.

“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.”

Tech challenges

The fact mRNA vaccines are a relatively new technology was also a challenge because, under NIH guidelines on research involving recombinant or synthetic nucleic acid molecules, such vaccines much be reviewed by an independent biosafety committee (IBC).

These requirements prompted the Advarra partnership according to IQVIA, which wrote it “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.”

Another challenge was the need to include clinical sites that had little experience trialing such projects according to IQVIA, which cited Advarra’s involvement as key to addressing this issue.

“Many sites were new to research using genetically engineered compounds, and needed education on the IBC process and product handling standard operating procedures (SOPs).

“The IRB and IBC partner also needed to work directly with the IQVIA site activation teams to coordinate all reviews, so first patient/first visit at each site could occur rapidly after the site initiation visit (SIV) was complete.”

Results

And partnering had the desired effect according to IQVIA, which said that average IBC approval timelines were reduced to under 2 working days.

Similarly IQVIA said that trials sites averaged 78% faster approval than non-COVID sites and activated sites to “ready to enroll” 71% faster than non-COVID sites, with patients enrolled the same day as site activation.

Image: iStock/Image: iSTock/EtiAmmos

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