Verified Clinical Trials and Quorum IRB Review have developed an expedited research subject authorization review process that reduces cost and time. Research sites, CROs, and pharmaceutical sponsors will benefit from this alliance in an effort to stop dual enrollment in clinical trials and reduce significant protocol deviations
Garden City, New York (PRWEB) January 19, 2015
Verified Clinical Trials (VCT) is the leading North American research subject clinical trials database registry that prevents dual enrollment in clinical trials by professional research subjects and helps avoid significant protocol deviations in clinical research trials. Quorum Review IRB is one of the largest IRBs in North America with a mission dedicated to the ethical protection of research participants and facilitation of the clinical research process.
By working together in a strategic partnership, Verified Clinical Trials (VCT), and Quorum Review IRB have created and streamlined a simple process to improve research subject safety and improve data quality. The new process leverages VCT’s research subject database at the research site level. Working together, both companies have developed a research subject authorization form to be utilized by research site staff, when employing Verified Clinical Trials’ services.
VCT services allow the research site staff to check multiple inclusion or exclusion criteria such as concurrent enrollment, prior compound exposure, half-life violations or current screening at another site immediately following consent and authorization form execution. Quorum Review IRB has developed a landing page on their company website for expedited review of the authorization form allowing easy access. This process results in both cost and time-savings.
“We recognize that there are many added demands and costs to conducting a clinical trial” stated Mitchell Efros MD, founding partner and President & CEO of Verified Clinical Trials. Dr. Efros added, “We wanted to address these challenges and have developed a new solution and process to improve the experience for companies that conduct clinical research.”
Kerri Weingard, ANP, founding partner and COO of Verified Clinical Trials, adds, “Prior to VCT, research site users were not able to verify many critical exclusion criteria. VCT provides the research site users a de-identified HIPAA compliant tool to look into the research subject’s study history across the entire VCT database and provide answers to those previously unknown data points detailing a research subject’s prior study history.
“Verified Clinical Trials now encompasses the majority of early phase units in North America as well as late phase sites and we wanted to make the process even smoother for our research site users. We applaud Quorum Review IRB for understanding the need for an ID-metric HIPAA compliant database in the clinical trial space and the demand to utilize a tool such as Verified Clinical Trials to improve the safety and data quality. Quorum Review IRB has not only identified this need, but has taken action and helped enable a simplified expedited process to a much needed solution.”
“Quorum Review IRB believes that the work we’re doing with Verified Clinical Trials directly supports our core mission of protecting research participants,” says Cami Gearhart, CEO of Quorum Review.
About Verified Clinical Trials:
Verified Clinical Trials is a forward thinking company developed by experts active in the clinical research community to proactively improve research subject safety and data quality in clinical research trials. Verified Clinical Trials halts dual enrollment in clinical trials and prevents several significant protocol deviations in clinical trials. Verified Clinical Trials is the only clinical research database registry designed specifically to enhance the quality of both early and late phase trials in all disease entities and has the scalability to reach all sites nationally as well as on a global level. Verified Clinical Trials offers numerous other value added services to the clinical research site, CRO, and Pharmaceutical Sponsor, that prove invaluable with regards to financial and legal issues and liabilities. For more information, RSVP to or visit http://www.verifiedclinicaltrials.com.
About QuorumReview IRB:
Quorum Review is an independent institutional review board fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and has been providing ethics review of human clinical research since 1992. Quorum oversees research in accordance with U.S. and Canadian human subject research protection regulations and guidelines set forth by the International Committee on Harmonisation (ICH), and principles of the Belmont Report. Quorum’s best-in-class IRB services include 15 Board meetings each week plus expedited review, 24-hour site review turnaround, 36-hour amendment review turnaround, a secure web portal, and Smart Forms for online submissions. Quorum’s IRB service offerings include full study review in the US and Canada, international ethics review, a specialized Phase I team, and unique processes for minimal risk research.