Case Study: Parexel achieves rapid mRNA and gene therapy study startup with Advarra's integrated IRB/IBC review

Leading CRO Accelerates Startup with Integrated, Centralized IRB/IBC Reviews

Parexel, a leading CRO, faced the challenge of accelerating study startup for multicenter trials involving genetically engineered materials (mRNA and other gene therapies) without extending timelines due to additional NIH-guided IBC reviews alongside IRB oversight. To meet tight site activation and first patient–first visit targets, Parexel partnered with Advarra and its integrated IRB/IBC review services, leveraging Advarra’s Gene Therapy ReadyTM site network and CIRBI platform to streamline submissions and pre-plan site-level biosafety procedures.

Advarra integrated into Parexel’s startup strategy by providing a dedicated IRB/IBC client success partner, real-time status updates, pre-review support, and biosafety expertise, enabling rapid approvals—IBC averaged 1.8 days (N=121) and IRB 1.7 days (N=145) from complete submission to approval, with 87% of sites from Advarra’s Gene Therapy ReadyTM network and many approvals posted the next business day. This collaboration delivered on-time, on-budget first patient/first visit performance, with Advarra holding 68 IBC meetings in one week and nearly all 145+ sites reviewed and approved within weeks, helping Parexel de-risk startup and accelerate critical vaccine and gene therapy trials.

Parexel

Teri Karcher

EVP, Head of Launch Excellence and Chief Drug Development Officer