With the launch of its clinical site accreditation program, ACRES has taken the first step toward its larger goal of creating a clinical research infrastructure that is digitally connected and operates under a single set of standards across the world.
The not-for-profit Alliance for Clinical Research Excellence and Safety (ACRES) announced its first accreditation program in July. It is the product of the first of seven initiatives the organization has embarked on to overhaul clinical research on a global scale.
Regulatory, safety and quality standards are largely fragmented across different countries, as are ethical norms.
Where international guidelines exist, such as those from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and International Organization for Standardization (ISO), they don’t go far enough to provide guidance in how to ensure staff are well-trained, data are safeguarded or data meet quality requirements for global