NEW YORK -- Clinilabs, an early phase and specialty CRO that provides clinical drug development services to industry, today announced that it has launched a subject authentication initiative at its Phase 1 sites in New York and New Jersey. This initiative includes the authentication of subject identity and medical history, background checks, and tracking of prior study participation in order to eliminate ineligible subjects from clinical trials. The Company has selected Verified Clinical Trials (VCT) to assist with this initiative, implementing the VCT database registry system. VCT's registry is designed to stop the professional research subject from enrolling in multiple clinical trials simultaneously – a situation known as dual enrollment. This collaboration between Clinilabs and VCT is a reflection of both companies' commitment to volunteer safety and data quality.
Failure to document the identity of study volunteers, inaccuracies in subjects' medical histories, and multiple concurrent enrollments have become a serious problem in the clinical research world. Study volunteers interested in free care or compensation may present inaccurate information in order to gain entry to clinical trials, and some may jump from one study to another without waiting for enough time to lapse between treatments. This type of research volunteer places everyone at risk including the drug manufacturer, the research site, and most importantly, themselves, potentially jeopardizing their health. Furthermore, this may compromise data quality.
Clinilabs and Verified Clinical Trials are determined to meet the challenge of subject enrollment in a proactive way, ensuring that only eligible subjects are enrolled in clinical trials. Dr. Gary Zammit , President and CEO states, "Most of us in the industry recognize the existence and the significant ramifications of improper enrollment in clinical trials, but we have never before been able to quantify it, detect it, or stop it. Clinilabs has taken the lead among CROs to provide its clients with a thoughtfully-conceived approach to subject authentication – ensuring the accuracy and integrity of volunteer data."
Dr. Mitchell Efros , CEO of Verified Clinical Trials states, "Clinilabs has joined an impressive cohort of companies on a local and national level to improve the quality of their trials. The recognition of dual enrollment in clinical research and use of the VCT system has literally exploded as of late". Dr. Efros adds, "We are very excited to have a company like Clinilabs join our expansive network that includes and focuses on both early and late phase trials. Clinilabs has joined the largest clinical research database network across North America and only strengthens this cooperative registry."
About Clinilabs Inc.
Clinilabs is a full-service contract research organization (CRO) that specializes in early-phase studies, from first-in-human to proof-of-concept, with normal healthy volunteers and patient populations. The company owns and operates two Phase I units in the US, and maintains a network of highly qualified investigator sites for multicenter Phase II studies Worldwide. Specialty projects, including pharmacodynamic, biomarker, cardiac safety, sleep/wakefulness, metabolic, and Japanese bridging are among our strengths. Clinilabs is recognized globally as a leading specialty CRO, offering an alternative to large CRO for specialty projects. For more information, please visit www.clinilabs.com.
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 defines itself as the world's leader in the field of database registries in clinical trial research. Verified Clinical Trials is the only clinical research database registry designed specifically to enhance the quality of both early and late phase trials 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, visit http://www.verifiedclinicaltrials.com.