Have you heard that the US Food and Drug Administration (FDA) will soon require Single Institutional Review Board (sIRB) review for all multicenter clinical trials (MCTs)? This FDA single IRB mandate aligns with new US law as stipulated in the 21st Century Cures Act.

Stated FDA: “We expect that with very few exceptions, every Life Sciences Sponsor or their contracted CRO will need to choose a single IRB to oversee each future clinical trial.

While the date the single IRB mandate becomes effective is still uncertain, you can reasonably anticipate it will become a requirement by the second quarter of 2024 (Q2 2024), if not sooner. This date is fast approaching, and you should begin preparing for the mandate now.

WCG IRB has deep experience helping ensure that the requirements of each clinical site and its local IRB are consistent with our central review. As THE FIRST Independent IRB in history, WCG IRB does this seamlessly. The processes at WCG are neither simple nor rigid — we understand that your study has unique requirements. We ensure that your trial is reviewed as expeditiously as possible, with utmost focus on quality and dependability. No other independent IRB can make this claim.

The Most Experience + The Largest Network = A Winning Combination

Spanning the largest network of Central Sites & Institutions of any Central IRB, WCG IRB has reviewed over 62,000 studies across nearly every therapeutic area in over 300,000 sites across North America over the past 20 years. In addition, we’ve amassed contractual partnerships with over 3,300 institutions. Our breadth of experience ensures something that no other IRB provider can offer: we know how to work with your site list— regardless of size.

By tapping into our partnerships, you gain unmatched expertise, one-of-a-kind insights, and a confident path to ensuring on-time study reviews. That’s why 93 per cent of all FDA-approved clinical therapies have involved WCG!”