LONDON, ENGLAND – September 10, 2008 - Quintiles Guy’s Drug Research Unit (GDRU) today announced that it has been awarded supplementary accreditation for Phase I clinical trials, under a new approval programme that has been introduced by the Medicines and Healthcare Regulatory Agency (MHRA). This voluntary accreditation builds on existing regulation, giving trial volunteers and customers added confidence that their facility and study meet robust clinical and safety standards.
With this accreditation, Quintiles GDRU will continue to conduct the full range of Phase I trials, including those first-in-human studies that are subject to review by the Clinical Trials Expert Advisory Group.
Paul Hargreaves, recently appointed Head of Quintiles GDRU comments: “Quintiles GDRU has worked closely and consulted with the MHRA during their review of how first in human studies on innovative low molecular weight chemical entities and biologics should be conducted. This new voluntary accreditation scheme is an important step in ensuring ever-better standards of safety and risk management in Phase I trials.
“The expert team at Quintiles GDRU has a relentless commitment to safety and quality; the MHRA accreditation is evidence of that. We will continue to work with pre-clinical information and consult closely with our team of specialists across disciplines, to ensure that each Phase I study is designed to the highest standards.”
Phase I accreditation has been introduced in line with recommendations made by the MHRA expert advisory group in response to the TGN1412 incident in 2006. It formalizes routine inspections and provides additional scope and depth to existing procedures for good clinical practice inspections.
Quintiles Transnational Corp. is powering the next generation of healthcare by providing a broad range of professional services in drug development, commercialization and strategic partnering for the pharmaceutical, biotechnology and medical device industries. With more than 21,000 employees and offices in more than 50 countries, it is focused on providing customer-centric solutions that are the gold standard of the industry. For more information, please visit the company’s Web site at www.qtrn.com.