COSTA MESA, Calif.,/iReach-PRNewswire/–WCCT, an international specialized contract research organization, announced today that their large Phase 1 research site has received CLIA Certification for its in-house reference laboratory.
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 determine the standards that apply to all clinical laboratory testing being performed on human subjects in the United States. The status of the Phase 1 CPU’s license was granted effective April 20, 2017, after a thorough inspection of the company and laboratory’s documents, instruments, Standard Operating Procedures, and staff competencies and experience. WCCT was granted the highest accreditation possible from CLIA, permitting the company to conduct moderate-to-high complexity testing, including both instrument-based and manual testing.
The reference laboratory was completed early in 2017, allowing the clinical diagnostic testing to be conducted in-house at the company’s 150 bed Phase 1 research site. Testing services can now be fully extended to WCCT’s clients for current and upcoming clinical programs.
The laboratory is equipped with fully-automated diagnostic testing machinery supported by robotics systems and software, and is capable of conducting hundreds of assays for general chemistry, therapeutic drug monitoring, toxicology, urinalysis, and more. The laboratory is overseen by WCCT’s Laboratory Director, Dr. Dana Yee, a trained pathologist and one of WCCT’s clinical investigators.
“The addition of the reference laboratory to our Phase 1 research site and our recent CLIA certification are of great value to the company and provide a distinct benefit to our current and future clients,” commented Jon Rojas, WCCT’s President of Early Clinical Development. “Where we would have previously needed to outsource most of our diagnostic testing to third parties, we are now able to bring this work in-house, resulting in increased efficiencies, oversight, and cost effectiveness for our clients.”
WCCT looks forward to expanding its capabilities in this area and is committing to establishing the premier Phase 1 CPU for early clinical programs of any size.