London-based British Standards Institution (BSI), which promotes excellence through standards development for business processes globally, and Massachusetts-based Alliance for Clinical Research Excellence and Safety (ACRES), a multi-sector collaborative building a global system for clinical research, have announced a major strategic partnership to promote excellence and improve quality and efficiency in medical product development worldwide.
BSI joins ACRES ongoing Site Accreditation and Standards Initiative (SASI) with the intention to develop and implement standards of excellence for clinical research sites and engage with all parties of the clinical research endeavor to develop an innovative process for “dynamic accreditation” of research sites that will promote, recognize and reward excellence.
BSI and ACRES also announced their intention to create professional stakeholder groups to oversee and maintain the standards, and to operate the global accreditation process.
Formed in 1901 as the world’s first national standards body and providing services to more than 70,000 sites in 150 countries across a range of industry sectors, BSI brings deep experience in standards development and accreditation processes to ACRES efforts. BSI and ACRES will work with stakeholders from across the clinical research endeavor in developing both the standards and the system for independent third-party accreditation.
Gary Slack, SVP for Global Healthcare at BSI, announced the new partnership, noting, “BSI believes excellence must be a habit, that excellence and responsibility must be embedded in sustainable business practices, and by doing so, improved quality and effectiveness are not just achieved, they are inevitable. We share these beliefs with ACRES and are excited to be part of these long-overdue efforts.”
SASI, building on its previous efforts in surveying and consulting on current site quality criteria, is constructing a comprehensive set of standards covering essential domains of patient and subject engagement and protection, site personnel, research integrity, facilities, information systems and data management, management and administration as well as quality management. These standards and derived metrics will enable an innovative “dynamic accreditation” process that automatically monitors operational data in real time to continuously improve site and system performance, benefitting stakeholders while minimizing research site burdens.
“High-performing quality research sites are critical elements in a safe, effective system for testing new medical products and doing clinical research to develop new therapies. For too long we have failed to recognize and reward truly excellent, professional sites and lacked a system for doing so. No more. This is true transformational change, a new way of doing things, and the expertise that BSI brings to ACRES global collaboration brings the future much closer than anyone could have imagined”, said ACRES president and co-founder, Dr. Greg Koski.
Arti Bajpai, co-chair of ACRES Global Standards Working Party developing the standards, commented “ACRES will not itself create nor hold the standards—as an enterprise-wide effort, everyone—sites, sponsors, CROs, ethics review committees, patients, providers and regulators—has a stake in the standards. Like the accreditation process itself, they too must be dynamic.”
Bajpai, president of Pennsylvania-based Compliance and Quality Integration (CQI) Consulting, and co-chair Dr. Amir Kalali, head of the Neuroscience Center of Excellence at Quintiles and co-founder of CNS Summit, are currently assembling domain-specific standards teams to coordinate and evaluate the new standards, targeted for public comment and evaluation in 2016.