Statement on European Clinical Trial Rules
Contact: John Lewis
ACRO Statement on European Commission’s
Proposal for Clinical Trials Regulation
July 18, 2012 – WASHINGTON, DC – Today, Doug Peddicord, PhD, Executive Director of the Association of Clinical Research Organizations (ACRO), made the following statement regarding the European Commission’s proposal for the regulation of clinical trials.
“The Association of Clinical Research Organizations (ACRO), whose members employ more than 25,000 medical research professionals throughout Europe, applauds the Commission’s efforts to simplify the rules governing clinical trials throughout the European Union. ACRO is especially pleased that the Commission has followed our recommendations regarding the coordinated assessment of clinical trials, streamlined reporting and increased transparency. We also commend the Commission for promoting a flexible approach to the oversight of research conducted in multiple EU Member States and engaging in a global regulatory framework. We look forward to working with the Commission to further clarify the roles and responsibilities of Ethics Committees, the implementation of a clear risk-based approach to quality clinical trial management, the adoption of sound data privacy standards and guidelines for insurance verification requirements.”
The Association of Clinical Research Organizations (ACRO) represents companies that provide a variety of specialized services that support the development of new pharmaceuticals, biologics and medical devices. The association provides an active voice for the CRO industry globally. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ approximately 75,000 professionals worldwide and annually conduct more than 11,000 clinical trials involving nearly two million participants in 115 countries. For more information, please visit www.www.acrohealth.org. Twitter @acrohealth. YouTube @ACROHealthChannel.