CHICAGO – May 5, 2011

The Food and Drug Administration (FDA) released guidance in May 2007 supplementing 21 CFR Part 11 to assist the industry in the use of computerized systems in research. These suggestions are aimed to provide confidence in the reliability, quality, and integrity of electronic records used in clinical investigations.

The guidance outlines suggestions in maintaining electronic records that are used to create, modify, maintain, archive, retrieve, or transmit clinical data. Among the suggestions proposed by the FDA, study protocols should identify each step in which a computerized system will be used and standard operating procedures (SOPs) should be in place to aid study personnel in successful and secure operation of IT systems. The FDA also recommends the implementation of audit trails, limited access, and training programs for programs utilized.

“GuideStar® has and will continue to implement the recommendations associated with this FDA guidance to maintain compliance where applicable,” says Greg Vaughan, Chief Technology Officer for GuideStar® Clinical Trials Management. “Customer implementations include internal and external system safeguards, as well as SOPs which address a system’s purpose, use, maintenance, disaster recovery, and security measures.”

About GuideStar®

GuideStar® Clinical Trials Management is a comprehensive, outsourced clinical research company for medical facilities across the country. It provides “private label” clinical research departments for hospitals, physician practice groups and health care centers. Through GuideStar®, these facilities have a cost-effective means to be at the forefront of clinical trials for the benefit of patients, attractiveness to physicians, and enhancement of their own reputation.

GuideStar® holds in the highest regard the principles governing clinical research. It recognizes the precision of execution, efficiency and operational excellence needed to navigate client partners through the complex, multi-layered processes of FDA compliance and industry regulations. For more information, please visit www.GuideStarClinical.com.