Verified Clinical Trials and Quorum Review IRB have developed an expedited research subject authorization review process that reduces cost and time. Research sites, CROs and sponsors will benefit from this alliance in the effort to stop dual enrollment in clinical trials and reduce significant protocol deviations.
Verified Clinical Trials (VCT) is a Garden City, N.Y.-based, 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 trials. Quorum 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. It is headquartered in Seattle, Wash.
By working together in a strategic partnership, VCT and Quorum 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 site level. Working together, both companies have developed a research subject authorization form to be utilized by site staff when employing VCT’s 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 has developed a landing page on its web site for expedited review of the authorization form, allowing easy access. This process results in both cost and time savings.
"We recognize there are many added demands and costs to conducting a clinical trial," said Mitchell Efros, M.D., founding partner, president and CEO of VCT. "We wanted to address these challenges and have developed a new solution and process to improve the experience and reduce costs for companies that conduct clinical research. Our alliance with Quorum Review IRB facilitates these goals."
Kerri Weingard, ANP, founding partner and chief operating officer of Verified Clinical Trials, said, “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 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.”