Anaheim Clinical Trials, A CenExel Clinical Research Center of Excellence, Wins Audit "Triple Crown"
Research Center Completes Independent FDA, EMA and PMDA Regulatory Audits Without Violations
SALT LAKE CITY and ANAHEIM, Calif., Sept. 9, 2019 /PRNewswire/ -- CenExel Clinical Research, Inc., ("CenExel" or the "Company") announced that Anaheim Clinical Trials (ACT), an adult and pediatric Phase I through Phase IV clinical research Center of Excellence, recently underwent three separate routine national agency audits within 45 days. The three agencies responsible for the protection and promotion of public health included the US Food and Drug Administration (FDA); the European Medicines Agency (EMA); and, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Each agency individually concluded their inspections citing no significant objections or violations.
"This may be an industry record – three consecutive audits within 45 days by national agencies with no FDA Form 483 or equivalent notifications," said Patrick McLaughlin, CEO of ACT. "Moreover, these three audits were prompted by our high enrollment in multiple clinical trials. The consistent quality of the data and the rigor of our Quality Assurance program were highlighted during these pivotal audits. This is a well-deserved accomplishment for everyone at ACT."
"Along with our nurses, doctors, and pharmacists, the hard work and continued dedication of each employee at ACT contributed to this successful outcome," added Dr. Peter Winkle, MD, FACG, FACP, CPI. "Our patients and sponsors have come to expect the high quality and outstanding service that ACT delivers."
"As a member of the CenExel site network, ACT has certainly lived up to the Center of Excellence best practices from which the name 'CenExel' was inspired," said Tom Wardle, CEO, CenExel.
The FDA and other regulatory agencies conduct periodic audits of clinical research sites for bioresearch monitoring purposes. A Form 483 is issued by the FDA upon completion of a facility site inspection, to document any concerns or observations found by the investigator which may represent violations of the US Food, Drug and Cosmetic (FD&C) Act.
For more information, please contact Linda Gundaker, Executive Vice President, Business Development at ACT, via email at [email protected] or mobile at 610-937-2006.
About Anaheim Clinical Trials
Anaheim Clinical Trials (ACT) is an adult and pediatric Phase I through Phase IV clinical research center located in southern California (Anaheim). ACT is one of the members of an integrated, multi-site network, CenExel, consisting of fully-owned and operated, clinical research Centers of Excellence (COE), and offering Phases I-IV with inpatient and outpatient capacities. In addition to healthy volunteers, ACT has been particularly successful in enrolling special patient populations in complex trials and Japanese subjects for ethno-bridging trials. Our certified Principal Investigators have the expertise and interest in a wide variety of therapeutic areas, including GI, CNS, pain, metabolic/inflammation, infectious disease, and respiratory. ACT has been recognized by our customers for excellent quality research, timeliness, high patient enrollment, and ease of doing business. For more information about ACT or its affiliates, please visit our website at http://act-trials.com or https://cenexelresearch.com/.
About CenExel Clinical Research
CenExel Clinical Research provides unparalleled medical and scientific support in the design and execution of clinical trials. The attention to detail assures quality, reliable results and has helped CenExel to consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in depth of experience, insight and tenure of the principal investigators and research staff in each facility. The CenExel Centers of Excellence deliver the expertise, engagement, and results to ensure that their clients achieve their clinical research goals. For additional information about CenExel Clinical Research, please visit www.CenexelResearch.com.
SOURCE CenExel Clinical Research, Inc.
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