Quorum Review IRB Debuts Simple Post-Marketing Process

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Quorum's service offering for post-marketing studies includes special pricing and a simplified application form for investigators.

Post marketing studies have been playing a greater role in the clinical trials landscape since the Food and Drug Administration Amendments Act of 2007 (FDAAA) became effective in March 2008 and recently, as the implications of health care reform become more clear. As these studies involve approved drugs or procedures and are typically limited to data collection, they involve less risk than Phase I-III trials. Additionally, these studies often involve larger numbers of sites, span a longer period of time and utilize many investigators who rarely, if ever, participate in clinical trials – and are therefore not as accustomed to the paper work that often accompanies Phase I-III studies.

In response to market needs, Quorum Review has created a service offering specifically for these post-marketing studies. This latest service offering includes price breaks to accommodate long study durations and high volumes of sites. Quorum’s investigator application form for post-marketing studies is short, clear and requires minimal attachments. If any investigators do have questions, Quorum’s Site Support Team is available to answer telephone calls from 8:00 a.m. Eastern time to 5:00 p.m. Pacific time.

“We realize that investigators in post-marketing studies provide an important research service,” says Cami Gearhart, Quorum’s CEO, “and so we have built out our processes to provide as much support as possible.” Quorum is committed to continue to developing new service offerings as the market changes. This latest innovation is a reflection of Quorum’s continued efforts to be the IRB to whom clients turn when performance matters.

About Quorum Review
Quorum Review is an independent ethics review board that is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and has been providing ethics review of drug and device trials since 1992. Quorum oversees research in accordance with U.S. and Canadian human research subject protection regulations, guidelines set forth by the International Committee on Harmonisation (ICH), and principles of the Belmont Report.

Quorum’s best-in-class service and support includes 3 protocol board meetings a week, daily amendment board meetings, 24-hour site review, 36-hour amendment review, and a secure OnQ™ web portal for online submissions, downloads and submission status review. Quorum can review studies in the US and Canada, review federally funded studies and has a specially designated Phase I study management team. For more information, please visit http://www.QuorumReview.com.


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Arri Burgess
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