Site Optics & Quality Initiative (SOQI)
“Site-optics” is the ability to see what is happening throughout the clinical research system down to the site-level at any moment in time. This requires the deployment of information technologies and standards that support the collection and aggregation of critical operational performance and compliance data.
The ACRES Site Optics and Quality Informatics (SOQI) initiative seeks to utilize site-based performance data and metrics and system-wide informatics standards and functions that will ensure interoperability of clinical trials management systems, source-based data capture, data-warehousing and analytics to promote safety, quality, data-accessibility, operational excellence and industry collaboration across the global clinical trials ecosystem through a shared, open-access information technology platform. This initiative lays the foundation for “Dynamic Accreditation”, a technology-assisted, real-time process for evaluating site performance in accordance with the standards.
Building a Global Open-Access Technology Interface
No system can function effectively without its components being connected and inter-operable. Although technologies and standards needed to support such a system are readily available today, their adoption has been limited and their full-potential remains largely untapped.
The existence of a system that incorporates standards for connectivity and provides incentives for adoption of technology, including a network of sustainable, professional sites that can benefit from being part of that system, will drive widespread adoption and more effective utilization of technology with dramatic, positive impact for all stakeholders, including sponsors, sites, regulators, service providers, ethics committees and patient-subjects.