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.
ACRES Global Technology Platform
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.
An Integrated Network System
The ACRES Technology Consortium
To jump-start the development and implementation of this shared global information platform, a committed group of technology providers and standards organizations have joined forces and resources to integrate their already proven technologies to create a universal “interface-engine” to support interconnectivity and inter-operability across the network while providing important tools to support and improve efficiency, safety, compliance and operational excellence at significantly lower cost and considerably more quickly than would otherwise be possible.
Key functionality includes an extensive database of sites and profiles of their capabilities; a platform for archiving and sharing critical credentials, training records and other documents needed for investigator and site-qualification and trial start-up; tools for implementation and support of quality risk management; performance dashboards; work-flow facilitation tools other cloud-based applications to promote efficiency and regulatory compliance, and others. By encompassing existing standards for data collection and interchange, and security, while making the system accessible and affordable for all stakeholders, this interface will drive more effective use of these technologies with enormous benefits. The interface will enable and support the collection of critical data at the point-of-origin in real-time; storage, interchange, aggregation across the enterprise; secure, shared and appropriately controlled access by key stakeholders; sophisticated analytics and support functions to improve safety, quality, performance and compliance oversight.
Dataflow Security Mapping Project
In collaboration with multiple stakeholders, SAFE Biopharma Association and ACRES have initiated a project to map the flow of information through the entire clinical trials process to identify information exchanges vulnerable to security or privacy breeches where enhanced security through identity proofing, authentication, non-repudiation and digital-signing solutions are needed.
Electronic Health Record (EHR) Integration in Clinical Research
Through their strategic alliance, ACRES and Fujitsu, Ltd., the world third largest information technology and communications company, are working together to develop improved methods for integrating EHR data into the clinical trials process to enable real-time improved safety and pharmacovigilance tools, remote risk-based monitoring, online auditing and enhanced post-marketing safety and health surveillance.