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Pearl IRB expands into compliance and consulting

Monday, October 17, 2011

Indianapolis-based Pearl IRB is expanding. The commercial institutional review board, launched just last year, is now adding a regulatory and compliance division, as well as a consulting division that will focus on helping life sciences startups.

The new divisions plus Pearl IRB now fall under parent company Pearl Pathways. “We’re having to re-brand ourselves, in a way,” said president and CEO Diana Caldwell. “We launched Pearl IRB only last year. Now we have to make sure folks understand the breadth of what we can do for them.”

Clients, said Caldwell, were requesting regulatory and compliance services. Before she and Pearl COO Gretchen Miller Bowker launched the IRB together, they had both been at Eli Lilly, and had been co-workers at regulatory compliance consultancy Safis Solutions.

“Before Pearl, both of us, in different capacities, focused on the regulatory approval process, so we have expertise,” said Caldwell, adding that when their IRB clients have run into snags with the FDA they have asked Caldwell and Bowker for assistance in the regulatory arena. The new regulatory division is called Pearl ReGXP.

The two started the consulting division for similar reasons. “People often approached us saying, ‘Will you help me? I’ll buy you lunch if you look at my PowerPoint proposal.’ We both had worked with startups before and we enjoy that,” she said. Pearl’s new consulting division is called Pearl IDEAS. Caldwell says she considers it Pearl’s start-up incubation division.

Over the next two years, Pearl Pathways will add about 20 employees to staff the new divisions. The IRB currently employs six staffers, along with about 16 others who work on an as-needed basis. Caldwell said clients can pick and choose among Pearl’s services, or buy them bundled.

The IRB itself is doing quite well since launching last year within the small-business incubator Indiana University Emerging Technologies Center. At that time, Caldwell said the goal was to fill the commercial IRB gap that stretched north to Minneapolis, east to Philadelphia, south to Cincinnati and west to San Diego.

Pearl promises speed, which is very enticing to sponsors. The IRB vows that if you can get your protocol in by the close of business Wednesday, Pearl will have a completed review ready the following Friday, in seven business days. 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 a client may not have received approval.

In July, Pearl partnered with Toronto-based Trafalgar Ethics Board to deliver integrated U.S.-Canada study reviews, as well as to join forces in offering medial writing, GCP/ICH assistance and site training to clients in both countries.

Caldwell and Bowker wouldn’t divulge the number of studies they are currently juggling, but Caldwell said, “It’s not handfuls, but it’s not hundreds and hundreds, either.”

Pearl is one of about 20 other commercial IRBs nationwide, and if Caldwell’s predictions are accurate, there soon could be many more. That’s because the Department of Health and Human Services in July announced it’s considering changes to the 1991 “Common Rule” to protect human subjects that, if they become regulations, could shift a lot of work to commercial IRBs.

The thrust of the proposed regulations, said Caldwell, would be to reduce burden, delay and ambiguity for investigators in studies taking place at multiple sites. That could spell less work for the slower institutional IRBs at universities and hospitals, and much more work for central IRBs that meet frequently and get work done fast.

Suz Redfearn

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