The Alliance for Clinical Research Excellence and Safety (ACRES), in partnership with the British Standards Institution (BSI), has launched a multi-stakeholder global working party to fast-track development of standards for all aspects of site work, laying the foundation for recognizing and rewarding excellence at clinical research sites worldwide and accelerating development of safe and effective new medicines.

ACRES and BSI announced advances in the third-phase of their global initiative to create standards for the accreditation of high-performing clinical research sites worldwide, thus promoting professionalism and excellence in clinical research while accelerating medicines development and enhancing clinical trials performance, safety and quality.

The Global Standards for Excellence (GSE) Working Party, formally launched in mid-November, brings together a team of global content experts from multiple domains to work with the BSI professional standards-writers to fast-track the development and testing of standards and metrics for assuring site excellence.

This announcement marks the continuing progress of the global accreditation effort launched by the ACRES enterprise-wide collaborative three years ago. Led by co-chairs Arti Bajpai, President, Compliance and Quality Integration (CQI) Consulting and Amir Kalali, vice president, Quintiles, the GSE Working Party encompasses ten cross-functional teams working across seven core domains and three specialty domains to create standards to provide the foundation for globally recognized accreditation of research sites.

Standardization and accreditation has been shown to substantially improve connectivity, interoperability, productivity, sustainability and efficiency in the conduct of clinical trials, reducing time to start-up and study completion, thereby accelerating the clinical trials process and medicines development.

Domain Team Leaders include: Anthony Rissling, CTMG; Katie Porter, Hamilton Health Sciences; Mary Westrick, University of Wisconsin; Ivo Ivanov, AstraNova; Sara Monday, ACRES; Penny Jester, University of Alabama at Birmingham; Nadina Jose, Anidan Group; Larry Kennedy, Quality Management Institute; Nonna Stepanov, Mountain State Health Alliance (MSHA) and Terry Stubbs, ActivMed Practices and Research. Steven Hirschfeld, NIH, will serve in a liaison role.

Over the next 6-9 months, the teams—each with 3-6 members bringing extensive experience in every aspect of clinical research—will work with professional standards writers from BSI to complete a set of draft standards. These will be circulated worldwide for review and comment by the entire stakeholder community—particularly research sites—but also sponsors, regulators, ethics committees, CROs, IT providers, investigators and patients. After revision based upon the comments and feedback, this initial set of standards will be pilot tested prior to a staged initiation of a unique accreditation process currently being developed in parallel with the standards.

The ACRES “Dynamic Accreditation” process, based upon proven high-performance models from other industries, will differ from traditional accreditation schemes by using information flowing in real-time during normal workflow to immediately identify potential challenges and opportunities for improvement, not unlike the air-traffic control feedback system utilized for global air transportation and safety.

Greg Koski, ACRES co-founder and CEO, noted that “prominent industry leaders, such as Freda Lewis-Hall, CMO at Pfizer and Briggs Morrison, CEO of Syndax Pharmaceuticals and a member of ACRES Board of Directors, have previously underscored the importance of high-performing sites in improving clinical trial performance. The standards and processes now being developed will provide an effective mechanism and incentives for sites to improve without imposing new bureaucratic and financial burdens.”

Sara Monday, ACRES VP of Site Development and Support and ACRES liaison between BSI and the teams, said, “In collaboration with BSI, our Domain teams include research professionals from around the world, each working toward one common goal: establishing standards of excellence in the clinical trials industry. This effort will bring much needed changes to our industry and will lead to the accreditation of research sites globally.”

Rob Turpin, Healthcare Market Development Manager, and Bei Ma, VP, Global Healthcare Development, are leading the BSI contribution. Turpin noted that BSI’s partnership with ACRES "takes advantage of a unique opportunity afforded by its multi-stakeholder global alliance to accelerate the development of standards that will surely enhance the entire clinical research and drug development process. We commend ACRES for its leadership of this challenging yet immensely valuable process and are delighted to be part of it.”