Testing of ACRES Quality Standard Featured in Outsourcing-Pharma

The Alliance for Clinical Research Excellence and Safety (ACRES), announced today a 10-year exclusive agreement with EXOCHAIN CORP to provide blockchain protocols as infrastructure to verify the secure identity of patients and doctors participating in clinical trials and enhance all aspects of clinical research and practice.

ACRES is a global non-profit multi-stakeholder alliance with more than 140 strategic allies worldwide. Their shared mission is to build, implement and maintain an integrated, comprehensive global system for clinical research that is effective, innovative and ethical.

A significant challenge to this goal is securing the health data of patients participating in clinical trials, a necessary step for its utilization and sharing amongst researchers and healthcare providers. EXOCHAIN’s new blockchain protocol addresses this challenge.

As Greg Koski, ACRES President and co-founder noted, “Precision medicine and personalized medicine is the future, where evidence-driven practice is integrated with, and informed by, high-quality research. Done correctly, this approach requires enterprise-scale access to information from millions of patients in a manner that ensures secure identity and access management across locations and generations. Innovative application of blockchain technology, as ACRES is now doing with EXOCHAIN, provides the key to the success of this new paradigm.”

EXOCHAIN CEO and co-founder, Bob Stewart, who also serves as ACRES CTO and CISO, explains, “We are excited to work with the ACRES BlueCloud network to implement ACRES-guided standards for effectively designing and conducting clinical trials, standards which are designed to improve patient outcomes by delivering the right care, at the right time, and which require information derived from analyses of massive sets of shared data. Success of this approach depends on trust, accessibility, and immutability of shared data and transparency. This is a perfect use case for EXOCHAIN’s LYNK utility token—enabling secure lifetime and transgenerational medical record sharing between providers and patients and then, their progeny.”

To start, EXOCHAIN will integrate its new blockchain protocol to enable secure identity and access management for the BlueCloud.net collaborative networking platform that provides ACRES universal interface for interactions among all stakeholders in the clinical research and healthcare enterprise, currently with more than 1.3 million users.

The new LYNK token-based blockchain protocol developed by EXOCHAIN is also well suited to support many other secure transactions critical to the clinical research and healthcare environment, including adverse event reporting and adjudication, remote study monitoring and regulatory oversight, as well as other highly-regulated endeavors in which secure and trackable data-transactions are essential.

Koski added, “We at ACRES are both excited and grateful for all that Bob Stewart and EXOCHAIN bring to this partnership and vision, including a significant contribution from EXOCHAIN to ACRES upon execution of our partnership agreement”.

EXOCHAIN co-founder Major Dan Winschel, APA-C, a former Special Forces medic, who is currently a physician’s assistant for Veterans Affairs said, “EXOCHAIN believes in the vision and mission of ACRES, and we intend to support it as vigorously as we can. This is the beginning of a special relationship and we are proud to be part of the ACRES unique mission, especially in support of Task Force Dagger Foundation’s Operation Restore.”

Stewart will be announcing and presenting details of the new EXOCHAIN LYNK protocol and the ACRES partnership at the North American Bitcoin Conference in Miami, Jan 18-19, at the James L. Knight Center. Follow the events live via Twitter using hashtags #EXOCHAINLYNK #BTCMiami and #TNABC.

The Alliance for Clinical Research Excellence and Safety (ACRES) President and CEO, Dr. Greg Koski, and Dr. Larry Kennedy, Founder and CEO of the Quality Management Institute (QMI), announced that the two organizations will unite efforts to build and deploy a comprehensive professional quality management systems environment to enhance performance, safety, and efficiency across the health care and sciences ecosystem. The approach is modeled after similar highly successful efforts in the aerospace and air transport industries.

The new initiative, expanding upon their existing strategic alliance agreement, will bring QMI’s extensive expertise, online training programs and professional certifications in quality management into the ACRES Quality Continuum, providing a unifying framework for ACRES’ multiple system-building initiatives, in particular the ongoing Site Accreditation Standards Initiative (SASI).

Under the terms of the new partnership, Dr. Kennedy will join the ACRES management team as V.P. for Quality Management Systems and Chief Quality Officer (CQO). As V.P., he will assume broad responsibility for the development, testing and implementation of global consensus standards for high-performing sites of clinical research excellence while retaining his role as CEO of the Quality Management Institute (QMI). He will also serve as liaison between ACRES and the British Standards Institution (BSI), which is partnering with ACRES to create standards and processes for accreditation of clinical research sites.

Dr. Kennedy, who brings more than 30 years of systems engineering and quality management expertise from aerospace, business and nonprofit enterprises to ACRES, will provide QM leadership to support ACRES overall vision. He has been instrumental in the development of the ACRES Quality Continuum and will Chair the Site Accreditation and Standards Initiative (SASI) with support from co-chairs Terry Stubbs and Beth DiGiulian and advisors Amir Kalali and Arti Bajpai.

ACRES, a global non-profit collaborative working to build a comprehensive shared system for clinical research, has adopted QMI's 2QR® Curriculum for a High-Performing Work Culture as the foundation for the development of the SASI team and to assist Site Leadership in effectively deploying standards. The online, state-of-the-art 2QR® curriculum will be made available to all ACRES constituencies and will enable the broadening of ACRES collaborations across the health sciences and medicines development enterprise.

“The pursuit of high-quality outcomes is the common thread that runs through every effort to improve healthcare, research, and medicines development and it provides the framework for achieving excellence. But significant improvement means that quality management must be recognized as a professional discipline and as a cultural imperative within the ecosystem that is clinical research,” said Kennedy.

Under Kennedy’s leadership, the leaders and members of the 10 domain teams currently working to develop standards within SASI are obtaining professional certification in quality management. Terry Stubbs, President and CEO of ActivMed Practices & Research, Inc, and Administrative Co-Chair of SASI team agrees “This is such a positive move for the industry. The training programs will teach and then reinforce important business practices, helping research sites thrive when they apply what they learn and pass on this information to all members of their team. This will embed the new approach firmly within their day-to-day operations.”

“These developments come at a critical moment, when global leaders from industry, academia and government are calling for voluntary accreditation of clinical research sites as an effective means of enhancing and accelerating safe development of new medicines—ACRES remains at the forefront of these efforts as we continue to push forward”, said Koski.

ACRES objective and ensuing efforts to realize global accreditation of clinical research sites began 5 years ago. ACRES and BSI expect the initial version of standards to be ready for public comment by the 2nd quarter of 2018. Efforts to concurrently develop processes for “dynamic accreditation” are also underway. Pilot testing is expected to occur in 2018 with initiation of the accreditation process as early as 2019.

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