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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.

Interventional Concepts, a leading clinical research organization for innovative pharma, biotech and medtech development-stage companies proposing to conduct clinical trials in Colombia, and the Alliance for Clinical Research Excellence and Safety (ACRES), a multi-sector non-profit operating in the public interest and committed to transforming the global clinical research environment, have announced a Strategic Alliance, joining Interventional Concepts with current ACRES Allies in their efforts to build ACRES’ shared global clinical research system.

In addition to contributing expertise to ACRES Site Accreditation and Standards Initiative (SASI), Interventional Concepts will work with ACRES and other stakeholders to create ACRES-Colombia, an endeavor that will help link Colombia’s clinical research capacity and stakeholders to the world.

Interventional Concepts, dedicated to life science innovation, has been providing clinical trial regulatory, operational and logistics support since 2010 to development-stage life science startup companies looking for cost-effective clinical research sites in Colombia capable of conducting early-stage human studies. Strategically located close to the US East Coast and sharing the same time zone, Colombia has a free trade agreement with the US and a predictable national regulatory pathway for clinical trials—30 days for medical devices and 60 days for drugs, the fastest in Latin America. It has the healthcare infrastructure and business environment necessary for clinical trials—including the highest ranked hospital in Latin America, over 120 ICH GCP-certified sites and a population close to 50 million with universal healthcare coverage.

Interventional Concepts will work with Colombian institutions, organizations, and companies to set up an ACRES national affiliate in Colombia. ACRES-Colombia will create mechanisms to facilitate appropriate contact between ACRES and Colombian academic institutions, regulatory agencies, and professional associations and to identify opportunities to further develop ACRES-related initiatives. It will promote an all-encompassing system for clinical research in Colombia to ensure the quality, safety, and ethical conduct of trials, including site accreditation, qualification, and certification according to globally-acceptable standards and the communication mechanisms needed to address site-specific needs.

ACRES brings together stakeholders from across the international clinical research eco-system to collaborate on building a much-needed, shared global system for safe, high-performance, clinical research. “Efforts to enhance clinical research capacity and quality in Latin America are very exciting, and Colombia has stepped forward to take a leading role. We are delighted to be working with our colleagues there since a global system only works if it embraces, mobilizes and unifies local resources,” noted Greg Koski, ACRES Co-founder and CEO.

Julio G. Martinez-Clark, Interventional Concepts’ Chief Executive Officer stated, “We look forward to using our experience and expertise to further advance the international expansion of ACRES endeavor to create a collaborative global system for clinical research into Colombia; the first ACRES initiative in Latin America!”

"Bogota welcomes ACRES-Colombia as a catalyzer to transform the local clinical research sector into one that is internationally competitive and aligned with ACRES' vision to build a global system for excellence in clinical research based on the values of Integrity, inclusiveness, innovation and implementation," said Diana Gaviria, Executive Director of Connect Bogota.

GuideStar Clinical Trials Management, a company providing support services and strategies for clinical research programs around the United States, and the Alliance for Clinical Research Excellence and Safety (ACRES), a multi-sector, non-profit organization building a multi-stakeholder-driven integrated global system for clinical research, today announced their partnership to expand site accreditation and uniformity across the clinical research community to promote and reward excellence.

As a Strategic Ally, GuideStar will collaborate with ACRES on its Site Accreditation Standards Initiative, a project to promote professionalism and sustainability among sites conducting research. The initiative—currently assembling teams across multiple performance domains including: patient and subject engagement and protection; site personnel; research integrity; facilities; information systems and data management; management and administration; as well as quality management—focuses on collecting and developing standards for research sites. It also is establishing independent third-party accreditation and offers opportunities for research sites to undergo self and peer evaluations.

GuideStar is knowledgeable in research operations from years of experience in the industry and working with nearly 100 health systems, hospitals and academic medical centers and will lend its expertise, including best practices, to the ACRES initiative. GuideStar will collaborate with other ACRES Allies in creating site-sustainability standards, registration of sites in a global network, site optics for self-review, and third party oversight of accreditation.

Shirley Trainor-Thomas, Chief Marketing Officer for GuideStar, expressed her enthusiasm about the partnership and the potential it brings. “As a clinical research services provider, the GuideStar team constantly strives to bring our clients guidance to optimize their research programs,” comments Trainor-Thomas. “By partnering with ACRES, we will contribute the solutions and best practices that promote sustainability for research sites around the globe. We are excited to join others in the industry in playing a role in this very important initiative for research sites and patients alike.”

Greg Koski, ACRES Co-founder and CEO, added, “There can be no global system for clinical research without well-prepared clinical research sites, sites of excellence. To create a world of high-performing professional sites we must invest in them and provide both incentives and rewards for their efforts. It is imperative for everyone that sites be given the tools and resources to help them achieve these goals, assistance which GuideStar is wonderfully qualified to give and we wholeheartedly welcome them to our ACRES group of Allies.”

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