CHICAGO – June 30, 2011

In response to increased funding of the Federal Drug Association’s (FDA) Bioresearch Monitoring Program focused on ensuring the maintenance of human subject protection, the agency has increased research site audits by 76 percent from 2008 to 2010.

Additionally, the FDA partnered with the European Medicines Agency (EMA) in 2009 to jointly audit sites for GCP compliance, which has resulted in an increase of staff available to conduct site audits. The Director of the FDA’s Division of Scientific Investigations confirms that if a site has not been audited, it will be in the near future.

Research sites that typically rely on monitors from CROs and sponsors to review study data should take ownership and responsibility of their data quality through internal evaluations or via independent consultants who will analyze and make recommendations on the site’s processes or deficiencies. Sponsors and CROs also are relying on external consultants to review sites to ensure the quality of the data, since an FDA warning letter could result in restricted marketing for a device or drug application.

“GuideStar® is committed to aiding sites by proactively creating and maintaining an audit-ready environment through development of integrated guidelines, standard operating procedures (SOPs), audit tools and training programs,” says Rhonda J. Paz, PhD, CCRP, Vice President of Clinical Operations. “We are poised to partner with sites to ensure FDA preparedness by augmenting a site’s existing resources or arming sites with the knowledge, systems and capabilities to independently implement an internal audit-preparedness program.”

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.