BSI and ACRES Plan to Develop Global Accreditation Standards for Clinical Research Sites

January 12, 2016
Pharmaceutical Technology Editors

The British Standards Institution (BSI) and the Alliance for Clinical Research Excellence and Safety (ACRES) announced a collaboration to develop global standards of excellence for clinical research sites.

London-based British Standards Institution (BSI) and Massachusetts-based Alliance for Clinical Research Excellence and Safety (ACRES) on Jan. 12, 2016 announced a strategic partnership to promote efficiency in medical product development. 

BSI joins ACRES ongoing Site Accreditation and Standards Initiative (SASI) with the intention to develop and implement standards for clinical research sites and develop a process for accreditation. According to a press announcement from the organizations, BSI and ACRES intend to create professional stakeholder groups to oversee and maintain the standards, and to operate the global accreditation process. 

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, and quality management. 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. 

Source: ACRES