WIRB-Copernicus Group (WCG), the world’s largest provider of regulatory and ethical review services and software to support clinical research, announced that its Western Institutional Review Board (WIRB) company has been certified to ISO 9001:2008 by BSI, confirming that it operates an excellent quality management system.

“WIRB and its sister IRB, Copernicus Group, are the only two IRBs to have met ISO quality management standards and to have received ISO 9001:2008 certification,” commented WCG chairman and CEO Donald A. Deieso, Ph.D. “We are proud to have set a new high bar for quality management in ethical review.”

“At WCG, we are always looking for ways to increase efficiencies within the clinical research process while – most importantly – maintaining the highest standards of human subject protection,” added WCG chief compliance officer David Forster, JD, MA, CIP. “Achieving ISO certification is a powerful indicator of our commitment to continuous improvement in all aspects of our operations.”

Todd VanderVen, president of BSI Americas, stated, “WIRB is to be congratulated for its achievement of certification to ISO 9001:2008. Given Copernicus Group IRB’s earlier certification, WIRB’s achievement sends a clear message of WCG’s commitment to quality and dedication to continual improvement.”

All ISO 9000 standards are based on a series of quality management principles. They require company leaders to establish clear goals and objectives for their quality management system and endeavor to get all their employees involved. Participating companies adopt a strong customer focus with employees aiming not just to meet customer expectations but to exceed them. They also take both a process- and systems-based management approach, and strive for continual improvement in their company’s overall performance, using internal audits to track progress.

ISO 9001:2008 is implemented by more than one million companies and organizations in more than 170 countries, according to ISO.

One Company, One Solution. By packaging assessment, training and a management system toolset, BSI delivers a business improvement solution that combines it all in a comprehensive service offering and allows us to provide an integrated approach to meet the needs of the organization and embed excellence across the business.

ISO is the world’s largest developer and publisher of International Standards. ISO is a network of national standards bodies of 166 countries, with a Central Secretariat in Geneva, Switzerland.

WIRB-Copernicus Group (WCG) is the world's largest provider of regulatory and ethical solutions for clinical research. The company provides Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) reviews, and Human Research Protection (HRP), Good Clinical Practice (GCP) and Biosafety consulting services. Its technology offerings include IRB workflow management solutions (IRBNet), clinical trial management software for sponsors and contract research organizations (ePharmaSolutions), and Part-11 compliant online learning solutions for research professionals (WCG Academy).