ACRES' Global Standards Initiative for Clinical Research Sites Advances

The Alliance for Clinical Research Excellence and Safety (ACRES), a multi-stakeholder non-profit collaborative building a global system to enhance safety, quality and efficiency in clinical research, announced Phase 3 of its Site Accreditation and Standards Initiative (SASI). The third phase of the project begins formal development of standards and metrics for site accreditation. Teams of 5-7 experts drawn from the global stakeholder community will develop standards in at least seven domains: personnel, facilities, management, information systems, quality management, recruitment and enrollment, and research integrity. Additional cross-cutting teams in specialty areas, such as first-in-man studies and pediatrics will also contribute their expertise. The Global Standards Excellence (GSE) Working Party will be responsible for coordinating and integrating the standards development process. ACRES ally, Essex Management, will provide project support. Amir H. Kalali, Vice-President, Global Head, Neuroscience Center of Excellence at Quintiles and Arti Bajpai, President, Compliance and Quality Integration (CQI) Consulting will lead the effort as co-chairs of the GSE Working Party that will include experts with expertise in all aspects of clinical research site management and operations, quality management, and regulatory oversight from around the world.

Read the full release here.