Monday, July 9, 2012

Using AAHRPP Accreditation to Guide Expansion

Case Study: Schulman Associates Institutional Review Board
AAHRPP Accredited Since 2008

The Situation
Schulman Associates Institutional Review Board (IRB) had built a reputation as one of the nation’s leading independent IRBs. For decades, the Ohio-based company was known primarily as a reviewer of multicenter phase 2 and phase 3 clinical trials. In 2009, Schulman decided to branch out and capture a larger share of the single-site phase 1 market.

The Challenge
Schulman was proud of its commitment to quality and, in keeping with that commitment, attained AAHRPP accreditation in 2008. The company was looking to grow but wanted assurances that any new partner or venture would reflect Schulman’s high standards.

“We have always been absolutely unwilling to compromise on research protections and the quality of the review,” says Michael Woods, President and CEO, Schulman Associates. “At the same time, we provide the highest level of customer service. In our business, we have to.”

The Solution
The company took a two-pronged approach to growth, adding capacity from within and via acquisition. And AAHRPP accreditation played a key role on both fronts.

In October 2009, Schulman began providing research review services in Canada. The company added a Canadian IRB and earned AAHRPP accreditation for it. Two years later, Schulman acquired Independent Investigational Review Board (IIRB) of Florida. Like Schulman, IIRB was AAHRPP accredited.

“We would not have considered an organization that wasn’t AAHRPP accredited,” Mr. Woods says. “Increasingly, the expectation from sponsors and CROs [contract research organizations] is that their IRB will be AAHRPP accredited. Very often, our customers pose that question to us.”

The Results
Today, Schulman has clients from throughout North America, and every year it reviews hundreds of studies involving thousands of research sites. The company’s two-pronged strategy is proving successful. The total number of trials reviewed has increased significantly, as has the number of single-site phase 1 studies.

Thanks in part to AAHRPP accreditation, the assimilation of IIRB has gone smoothly. “Because we are both AAHRPP accredited, we followed the same standards and had the same high expectations,” Mr. Woods says, citing compliance with AAHRPP requirements for policies, procedures, and documentation.

“AAHRPP really worked with us to ensure that we could integrate the two organizations and maintain AAHRPP accreditation, and that’s important to us,” he adds. “In our industry, the way you distinguish yourself is through that magic combination of quality and customer service. AAHRPP accreditation helps us maintain that.”

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