Home Agency Inspections CenExel Clinical Research’s Anaheim Clinical Trials Passes FDA, EMA & Japanese PMDA...

CenExel Clinical Research’s Anaheim Clinical Trials Passes FDA, EMA & Japanese PMDA Inspections all Within 45 Days

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Businesswoman protects the quality work.

Webster Capital-based CenExcel Clinical Research Inc. (CenExel) was formed in 2018 with the merger of JBR Clinical Research, a Salt Lake City facility specializing in analgesia research and vaccine testing, with ACMR, an Atlanta-based psychiatric research facility. Since this formation, it has selectively pursued organic growth as well as the acquisition of other state-of-the-art research centers around the nation with the support of specialist investment bank Edgemont Partners. In early 2019 the group acquired Anaheim Clinical Trials (ACT), an adult and pediatric Phase I-IV clinical research site. Most recently ACT endured perhaps a first for any research site—enduring three separate audits from national regulatory inspectors within 45 days which is unprecedented.

Recently ACT underwent three separate routine national agency audits within 45 days. The three agencies responsible for the protection of public health included 1) The United States Food and Drug Administration (FDA); 2) The European Medicines Agency (EMA) and 3) the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Each national agency individually conducted their inspections citing no significant objections or violations.

CenExcel’s ACT Wins Triple Audit Crown

This author has been involved with clinical trials services and software supplier activity for nearly two decades and this news is relatively unprecedented—a clinical investigator site (with a handful of sites around the nation) is subjected to three separate national regulatory agency inspections. 

Evidence of a busy operation working with multinational clinical sponsors, “this may be an industry record—three consecutive audits within 45 days by national agencies with no FDA Form 483 or equivalent notifications” reported Patrick McLaughlin, CEO of ACT. McLaughlin continued “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.”

Tom Wardle, CEO of CenExel noted “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.

FDA Inspections

The FDA and other regulatory agencies conduct periodic audits of clinical research sites for bioresearch monitoring purposes. 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 U.S. Food, Drug, and Cosmetic (FD&C) Act. Again according to CenExel’s press release there were no significant findings.

TrialSite News Visit to CenExel

TrialSite News’ publisher and founder, Daniel O’Connor, recently visited CenExel’s Salt Lake City operation several weeks ago. An upbeat and positive interaction, CEO Wardle and VP Kevin Quinn provided a tour of their large, impressive facility not far from TrialSite News’ downtown Salt Lake City headquarters. The large size and scale of the operation were impressive. Wardle has some experience in this area—serving for 10 years as the Chief Operating Officer of Worldwide Clinical Trials (WTC), a full service, global contract research organization operating in more than 40 countries. Under his leadership, they grow from 400 employees to more than 1,400 employees.

The CenExel leadership explained their growth strategy as one of a carefully planned and executed advancement grounded in key areas of expertise, quality-driven high performing research sites and integrated systems and processes with an emphasis on patient safety, quality, and productivity. Back in July 2019, TrialSite News covered CenExel in the context of clinical research site space competition and consolidation. CenExel’s differentiation, we suggested focused on centers of excellence in select therapeutic areas as well as strategic geographic distribution (e.g. California, Utah, Georgia, and Maryland). CenExel’s nationwide reach is substantial and is backed by well-capitalized Webster Equity Partners which recently raised its fourth fund at $875 million. 

Call to Action: Are you a sponsor in search of high-quality clinical research sites focusing on areas such as pain management, vaccines, cardiovascular, CNS and diabetes, and metabolism-based studies, then it would be wise to review the CenExel offerings.

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