Case Study

Reliable Environmental Monitoring System Safeguards Life-enhancing Research

Source: Vaisala, Inc.

Founded in 1976, Associated Gastroenterology Medical Group (AGMG) in Anaheim, California and its research affiliate, Anaheim Clinical Trials (ACT), have conducted clinical research trials in all fields of medicine. Sponsored by pharmaceutical and biotechnology manufacturers around the globe, ACT develops new treatments for various gastroenterological diseases and conditions, conducting over a hundred clinical trials per year. The AGMG/ACT team, including doctors, researchers, nurses and staff, proudly provide cutting-edge treatment to patients at no cost in a state-of-the-art facility equipped with the finest available endoscopic equipment and staffed by expert personnel. The center is one of the few GI research and treatment centers in the nation to have a fulltime anesthesiologist.

Pharmaceutical manufacturers that sponsor the research conducted at the center continuously monitor the facilities, its processes, and adherence to FDA/EMA and other stringent regulations. The center receives five to fifteen visits a month from sponsor-company monitors who audit all facets of GxP compliance. During these visits, monitors request temperature records to ensure that all refrigerated and frozen drugs and samples are maintained within specifications. In addition, the ambient conditions of controlled environments must also be shown to have been continuously monitored for appropriate temperature and humidity levels.

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