Indiana now has its first commercial Institutional Review Board (IRB). Indiana and its surrounding region, that is. Diana Caldwell and Gretchen Miller Bowker—both Eli Lilly alum and former coworkers at the regulatory compliance consultancy Safis Solutions—have launched Pearl IRB to fill what they say is the commercial IRB gap that stretches north to Minneapolis, east to Philadelphia, south to Cincinnati and west all the way to San Diego.
The goal is that the new IRB will attract more trials to the Hoosier state. According to Caldwell, Pearl’s president and CEO, the idea for the IRB was born out of a meeting of the Indiana Health Industry Forum Task Force, formed last year to help foster growth of the health industry in the state. It quickly became focused on how to remedy the dearth of clinical research there.
“Indiana is under-indexed for clinical trials,” said Caldwell. “We get disproportionately fewer trials, when Ohio, next door, is a tremendous clinical trials state. One of the huge gaps identified was the lack of any commercial IRBs.” She added that anyone in Indiana who needed an IRB review either had to go through a review board at a hospital or university, which is time consuming, or work remotely with a commercial IRB out of state, which is purely transactional.
Caldwell and Bowker opened Pearl this year within the Indiana University Emerging Technologies Center, a small business incubator for technology and life sciences startups. Pearl’s goal, said Caldwell, is to be not only high quality, but also very fast and efficient and to foster tight relationships with sites, CROs and sponsors working within Indiana.
On the fast side, Pearl has this going for it: Caldwell and Bowker, along with their board members, have many decades of experience on both the sponsor and CRO sides. This, said Caldwell, sets them apart from many other commercial IRBs, which tend to be staffed by folks coming from careers with academic IRBs. “We at Pearl all come from a service mindset; Pearl will have a service-company bent,” she said.
Caldwell promises this: If you can get your protocol in by close of business Wednesday, Pearl will have a completed review ready the following Friday, seven business days later. This, said Caldwell, is in sharp contrast to other IRBs—commercial or otherwise—which not only take much longer, but also aren’t very communicative about when a review will be completed, or, once it’s done, why you may not have gotten the nod.
“Folks often say there’s a lack of clarity in the communication with their IRB, or that things in the review don’t make sense, or that the IRB didn’t seem to understand the science,” said Caldwell. “Our commitment is if you get a no or a conditional, you will know what you need to do to fix it, and that we will staff the board with the right mix of people to understand your technology.” Caldwell wants Pearl to be known as the IRB that communicates.
As Caldwell and Bowker have begun to spread the word about their IRB around the state, hospitals have asked them to consider handling the administrative back end of their IRBs. Caldwell said Pearl is adding this to its suite of services, which also includes training for IRB board members and principal investigators.
Pearl joins a pool of only about 20 other commercial IRBs nationwide. Caldwell said she expects the field to grow. “Commercial IRBs are saying their waiting lists are weeks and weeks long just to get into the queue,” she reported. “Because there is such a need, I think we’ll continue to see more and more get developed.”