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Anaheim Clinical Trials (ACT) Clears Another FDA Inspection


4/29/2014 11:41:47 AM

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Anaheim, California (April 28, 2014) -- Anaheim Clinical Trials (ACT), a leader in the conduct of clinical research trials just completed another FDA clinical study audit with no 483 violations issued. The audit was triggered by high enrollment in a vaccine trial with a large number of subjects enrolled in a short period of time.

"ACT’s commitment to quality and high enrollment certainly comes through every time,” said Peter Winkle, M.D., F.A.C.G, F.A.C.P., C.P.I., Medical Director and Principal Investigator, “I am really proud of our entire Team.”

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 managers are certified by professional organizations through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA). For the last three years, independent facility inspections and data audits have been conducted quarterly 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.

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-IV clinical research center, 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 complex procedures and therapeutic areas, including GI, pain, metabolic/inflammation, infectious diseases, 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, please visit our website at www.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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