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Anaheim Clinical Trials (ACT) Phase I Unit Passes FDA Inspection


12/7/2011 11:35:18 AM

Anaheim, California (December 7, 2011) – Anaheim Clinical Trials (ACT), an adult and pediatric, Phase I clinical research center, reports the successful completion of an FDA inspection conducted during December 2011 on a very large, in-patient bunion repair study for which ACT was the second highest enrolling site in the United States. No 483 violations were issued. To date, ACT has never received a 483.

Through a separate Quality Assurance department with two full-time employees, ACT is dedicated to ensuring quality data generated from the conduct of its clinical trials. Both QA analysts are certified by professional organizations through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA). Independent facility inspections and data audits are also conducted quarterly throughout the year by an outside firm, Clinical Research Audit Associates, New York. In addition, ACT Principal Investigators achieved formal recognition by ACRP as certified physician investigators (CPIs). This certification signifies that a physician possesses knowledge sufficient for the safe and ethical conduct of a clinical trial in accordance with the appropriate ethical, medical, scientific, legal and regulatory standards.

“We understand how important quality is to our study subjects, the pharmaceutical sponsors, our business, and most importantly, to the patients who will eventually take the medicine,” says Dr. Peter Winkle, M.D., F.A.C.G, F.A.C.P., C.P.I., Medical Director. “We are truly proud of our successful track record in conducting clinical trials, and our scientific contribution to the development of new drugs.”

The U.S. Food and Drug Administration (FDA) is authorized under the Federal Food, Drug, & Cosmetic Act (21 U.S.C. 374) to perform on-site inspections of clinical studies conducted to support research and marketing applications to the agency. The primary purpose of the inspection is to ensure the protection of research subjects and the integrity of data submitted to the agency in support of a marketing application. Any concerns discovered during an FDA inspection are documented and communicated to the Principal Investigator on a Form FDA 483.

About Anaheim Clinical Trials

Anaheim Clinical Trials (ACT) is an adult and pediatric Phase I clinical research center with full-service CRO capabilities, located in southern California (Anaheim). In addition to healthy volunteers, ACT has been particularly successful in enrolling special patient populations, such as renal- and hepatic-impaired patients, 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, please visit our website at http://act-trials.com.

For more information, please contact Linda Gundaker, Executive Director of Business Development, via email at lgundaker@act-trials.com or mobile at 610-937-2006


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