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 the 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.
Clinerion, an eClinical technology services provider located in Basel, Switzerland, and the Alliance for Clinical Research Excellence and Safety (ACRES), a Cambridge, Massachusetts-based non-profit organization operating in the public interest and dedicated to building a global system to enhance quality, safety, integrity and operational effectiveness in biomedical product development and health research, are pleased to announce their partnership for accelerating patient recruitment and promoting risk-based quality management.
By aligning with ACRES integrated data source capabilities housing valuable study and site information, Clinerion's Quality Risk Radar will be able to significantly extend its support of risk-informed decision making during the clinical planning and execution process and thereby maintain and exceed study quality standards. Risk based Monitoring (RBM) becomes a reality when applying Clinerion's consulting and technology services as they enable all clinical research organizations to start projects quickly and rapidly pilot the new RBM approach and enabling technology by taking advantage of FREE and discounted services that Clinerion has pledged to ACRES.
Clinerion will provide to ACRES real-time access to millions of electronic health records (EHRs) coupled with the use of its Patient Recruitment System to find on average 30 times more trial candidates than conventional screening.
"We are delighted to join the ACRES Global Network and are pleased to make our easy-to-implement, industry-hardened solutions in Risk-Based Quality Management and Patient Recruitment available to ACRES. We do this for free or at very attractive conditions and we are convinced that this will translate into significant progress toward the common goals of enhancing quality and operational effectiveness in biomedical product development and health research," said Ulf Claesson, CEO of Clinerion.
ACRES COO, Matthew Whalen, noted, “Our relationship with Clinerion — as a Strategic Ally offering innovative solutions that already exist — demonstrates our ongoing commitment to improve clinical research processes globally and accountably. We are excited to be going forward as allies”.