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The Alliance for Clinical Research Excellence and Safety (ACRES) announces a major advance toward a shared, open information technology platform for all-user integration across the biomedical research enterprise.
The Alliance for Clinical Research Excellence and Safety (ACRES), the global public-interest collaboration building a comprehensive system to transform clinical research, today announced a major second step toward full implementation of a multi-stakeholder shared information technology platform.
Technology solutions to enhance clinical trial performance are multiplying rapidly, but their usefulness is limited by their lack of connectivity and inter-operability. The new platform, dubbed Apollo, provides a shared infrastructure to support functional integration of existing technologies, including electronic health records (EHRs), electronic data capture (EDC) systems and clinical trial management systems (CTMS), and to enable data exchange and aggregation critical for development and implementation of “big data” analytics essential for next-generation methods for remote monitoring and auditing, real-time pharmacovigilance, and continuous quality improvement enterprise-wide.
The first phase of the ACRES global IT platform, built on the BlueCloud® 2.0 Networking Technology developed by ACRES’ Austin-based strategic ally HealthCarePoint, provided a common platform for users worldwide to share vital research study documents, including training documentation and verifiable professional credentials essential for study start-up.
With nearly 1,000,000 current member-users in healthcare, research, and industry globally, the BlueCloud® is already benefiting sponsors, CROs, investigators, research sites, regulatory agencies and ethics committees worldwide. Now, the second phase of this global collaborative platform, spearheaded by ACRES strategic partner HealthIDx, includes initial roll-out of a federated trust framework for secure enterprise-wide identity management and single sign-on access to multiple end-user applications on the ACRES Apollo platform.
Apollo utilizes a proven cloud-based integration platform-originally developed by Detroit-based Covisint to support the complex supply chain, distribution and marketing logistics of the automotive industry-to enable seamless connectivity and inter-operability of multiple applications across the industry’s diverse stakeholders, including sites, sponsors, CRO/SMOs, regulatory agencies and supply chain providers and ethics committees.
“We are delighted to be working with ACRES and its many allies in this important effort,” said J. Scott Lowry, Founder and CEO of HealthIDx. “In this next phase, which includes secure cloud-based data exchange, aggregation, visualization, and analysis, we are addressing critical challenges of security, multi-user identity management, and fine-grain access control.” Lowry further noted that several technology applications, including the BlueCloud®, have been integrated via open APIs onto the ACRES Apollo platform and more such integrations are planned, including platforms of other organizations, thereby extending their power, connectedness and effectiveness.
“The ability to acquire and exchange data seamlessly among a wide array of EHR, EDC and CTMS platforms within a secure cloud-based environment and move them into shared data vaults where they can be used in real-time will support clinical research performance, quality, safety and oversight as never before,” said Greg Koski, ACRES co-founder and CEO. “Apollo provides the ability to achieve true connectivity among the many applications already in use, as well as new applications being developed, across the entire drug development and clinical trials endeavor, saving time and money for all while creating innovative opportunities for creativity, efficiency and effectiveness.”
“This is a collaborative effort,” added ACRES COO Matt Whalen. “Rather than create a proprietary platform, ACRES is deploying a robust integration platform that can connect all stakeholders, whatever applications they currently use, in a timely and cost-effective manner. The power of this approach lies in what can be done through the application of soft systems engineering and the use of standards developed by organizations like OASIS, ICE, CDISC, GS1 and SAFE Biopharma.”
The Apollo platform also incorporates an “app store” to take advantage of the several technologies and point solution capabilities available to users, working in parallel with second-level integrations of EHR, EDC, CTMS and data management systems. A live demonstration of the Apollo’s robust systems capabilities for multiple high-value use-cases is planned in the second quarter of 2016. Additional applications from diverse providers are welcome.
The Alliance for Clinical Research and Excellence (ACRES) is a non-profit leveraging the expertise of stakeholders worldwide to collaboratively build a shared global system for clinical trials that are responsibly conducted according to the highest standards of safety, quality and efficiency, based in principles of Accountable Research™. Adapting lessons from industries that have successfully implemented principles of systems and safety engineering, this global system will employ integrated information technologies as well as interoperable standards, policies and practices to enhance clinical research safety, quality and efficiency worldwide.