A major initiative to create an integrated information-management platform supporting clinical research worldwide was announced today by the rapidly growing Alliance for Clinical Research Excellence and Safety (ACRES), a multi-stakeholder non-profit group building a global system to enhance safety, quality and efficiency in clinical research.
ACRES president, Dr. Greg Koski, introduced the collaborative effort at the 17th International Conference on Pharmaceutical Medicine in Berlin. Under a memorandum of understanding, a group of ACRES strategic allies, 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, are forming a consortium to develop the new interface supporting the open access global network of clinical research sites currently being built by ACRES and its strategic allies.
Key features 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.
The interface design will ensure interoperability with all CDISC-compliant EDC (electronic data capture) clinical trial management systems and will incorporate SAFE-BioPharma’s enterprise security standards and digital identity credentials.
The effort, part of ACRES Site-Optics and Quality Informatics (SOQI) initiative, 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.
“This is an extraordinary accomplishment and opportunity”, noted David Loose, managing partner at Essex. “The ACRES-convened consortium brings together existing, proven technologies to ‘leap-frog’ development and implementation of a much needed information platform, at a fraction of the time and cost required to do so from scratch.”
Al O. Pacino II, an ACRES VP and president of HealthCarePoint, added, “These technologies are already being used by the pharmaceutical industry individually, saving millions of dollars. Working together, as an integrated platform, their impact will be amplified.”
Mollie Shields Uehling, CEO of SAFE-BioPharma Association, agreed, saying “Creating a shared collaborative network system and IT interface will drive further adoption and implementation of standards globally and provide needed improvements in clinical trial efficiency and quality.” SAFE-BioPharma maintains the standard for digital identity and digital signatures used in life sciences and healthcare.
To fund the collaborative integration effort, ACRES will seek sponsorship from industry stakeholders. Sponsors will be able to immediately access and implement the existing individual technologies at deeply discounted rates and take advantage of significant savings, thereby realizing a real-time return on their investment.
The consortium anticipates staged development and implementation of the integrated interface platform over the next year at a total cost of under $10M USD.