Anaheim, California (January 26, 2016) – Anaheim Clinical Trials (ACT), an adult and pediatric, Clinical Research Center, reports that an FDA inspection was conducted during January 2016 on two, completed, Phase 2, adolescent studies for high enrollment. The FDA audit successfully concluded with no 483 violations issued.
“Again, we are proud that our hard work, high ethical standards and drive for quality is demonstrated in the results of our most recent FDA inspection.” says Dr. Peter Winkle, M.D., F.A.C.G, F.A.C.P., C.P.I., Medical Director.
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.
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 Vice President, via email at lgundaker@act-trials.com or mobile at 610-937-2006.
“Again, we are proud that our hard work, high ethical standards and drive for quality is demonstrated in the results of our most recent FDA inspection.” says Dr. Peter Winkle, M.D., F.A.C.G, F.A.C.P., C.P.I., Medical Director.
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.
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 Vice President, via email at lgundaker@act-trials.com or mobile at 610-937-2006.
