The Alliance for Clinical Research Excellence and Safety (ACRES) has unveiled a scheme to create an integrated information-management platform designed to support clinical research worldwide.
ACRES President, Greg Koski, M.D., PhD, introduced the collaborative effort at the 17th International Conference on Pharmaceutical Medicine in Berlin. Under a memorandum of understanding, a group including HealthCarePoint, ViS Research, Forte Research Systems, ii4sm, Verified Clinical Trials and InnovoCommerce, along with three global standards organizations, CDISC, SAFE-BioPharma Association and CareLex, is forming a consortium to develop the new interface supporting the open access global network of clinical research sites currently being built by ACRES and others.
The project will include archiving and sharing of professional credentials and study-related documents, sharing of site-capability profiles and demographics for site-qualification assessments, online performance dashboard, risk-based quality management analytics and support, and cloud-based tools for workflow-facilitation, enhanced compliance, safety-reporting and monitoring.
Part of the ACRES Site-Optics and Quality Informatics (SOQI) initiative, it will integrate existing technologies and standards of consortium members, enabling fast-track development of a seamless, secure site-network interface supporting coordination and oversight of critical system activities by stakeholders, including sites, sponsors, regulatory agencies and service providers. The first component, a global site-registration platform, was launched in preliminary form last fall, powered by Vis Research and HealthCarePoint.
The project will be coordinated by Essex Management, a Connecticut-based IT consulting firm, and overseen by a project steering committee chaired by Dr. Stephen Rosenfeld, of Quorum IRB and former CIO of the NIH Clinical Center, and Peter Schiemann, managing partner at Widler-Schiemann QMS, a quality management consulting firm located in Basel.
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