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.

Ethical GmbH, of Basel, Switzerland, a provider of Centralized Endpoint Adjudication solutions for clinical trials, and the Alliance for Clinical Research Excellence and Safety (ACRES), Cambridge, MA, a multi-sector non-profit organization building a multi-stakeholder-driven integrated global system for clinical research, today announced their strategic partnership.

This new collaboration, which brings Ethical GmbH into the ‘ACRES Alliance', a rapidly growing collaborative of innovation-focused organizations spanning the global clinical research enterprise, focuses on improving data quality and processes in clinical research by leading standardization efforts in Endpoint Adjudication in clinical trials.

Endpoint adjudication plays a key role in the approval of new therapies by regulatory authorities. However the current process is plagued by a lack of standards when dealing with existing subjective endpoints and the inconsistent use of independent review committees across disease states. Also, the conventional paper-based nature of endpoint adjudication adds to problems with time-consuming, inefficient and error-prone processes due to loss of adjudication dossiers or deficiencies in the endpoint adjudication decisions.

"Ethical GmbH and ACRES believe process efficiency, optimum utilization of scarce resources and data quality are critical for high quality clinical trials", comments Mimmo Garibbo, Director, Ethical GmbH. "As part of the ACRES Alliance and Technology Consortium, we can work together to address industry challenges and help eliminate tedious duplications resulting in higher costs and delayed availability of critically needed clinical trial data."

The collaboration will initially explore opportunities for streamlining and improving the Endpoint Adjudication process effectiveness. Ethical GmbH's Endpoint Adjudication solutions bring the Ethical eAdjudication® Platform to ACRES shared global platform of integrated technologies to improve the integrity of data and reduce trial costs. Ethical GmbH and ACRES will also explore development of shared standards across service providers, stakeholders managing Endpoint Adjudication Committees and sponsors. Ethical GmbH will participate in ACRES' Foundation Initiatives related to quality management, contributing to the “dynamic accreditation” process being developed by the Alliance.

The Ethical GmbH's eAdjudication® platform will give ACRES access to a fully validated system that provides an electronic “paperless workflow”, a role-based management of permissions and related workflows, the real-time, direct and controlled access to the study status, data, documents and adjudication decisions. In addition, the built-in quality control and metrics enables the users to exercise the oversight that GCP demands.

ACRES President and CEO, Dr. Greg Koski, said, "We are dedicated to developing an open-access global network of shared technology platforms, standards and processes to enhance performance, quality and safety in clinical trials through integration of existing innovative technologies. We are delighted to welcome Ethical GmbH. Together we can drive standards and aligned workflows to benefit all stakeholders, including sites, academic and commercial sponsors, CROs and, especially busy experts dedicating time and resources to the classification of clinical endpoint data that ultimately supports the work of regulatory agencies and is in the best interest of patients."

Following the recent meeting of a multi-sector global stakeholder consultation on clinical research site-excellence, strategic allies in the Alliance for Clinical Research Excellence and Safety (ACRES) Tech Consortium continue to deepen their support of the ACRES shared global clinical research system model as an effective initiative for accelerating medicines development.

To date, ACRES allies have pledged more than $102M in technologies and services, including e-compliance systems for investigator sites, networking technologies to share verifiable information in real-time between sponsors, IRBs, investigator sites, government organizations and regulatory agencies as well as other tools to assess and improve safety, quality, site efficiency and sustainability.

The inaugural meeting of the Global Stakeholders Consultation was held at the Drug Information Association (DIA) June 2014 Annual conference in San Diego, the first in a series of similar meetings to be held regionally around the world that seek broad input on how to optimize a global process and standards for accreditation of clinical research sites. Pfizer Chief Medical Officer, Dr. Freda Lewis Hall, opened the meeting with a stirring keynote address in which she voiced industry support for site-accreditation as a method to promote, recognize and reward high-performing, professional clinical research sites as industry transforms the way it conducts clinical trials.

“To date, ACRES is working with more than 65 industry and organizational allies and service providers, as well as global regulatory agencies and nearly 100 executives, senior managers and subject matter experts who understand how the ACRES open-collaboration model applies systems thinking to catalyze change and create value”, said Dr Greg Koski, President and CEO of ACRES, “and we are in discussions with additional organizations who are interested making pledges to support ACRES transformative approach.”

“A pledge is a commitment of measurable, fair market value resources by an ACRES Technology Consortium member or strategic ally that adds value and sustainability to stakeholders in the global clinical research enterprise, including investigational sites, sponsors, CROs, ethics committees, regulatory authorities, and the public,” said Al O. Pacino ll, ACRES VP for Collaborative Network Development.

“ACRES pledges of already existing effective technologies and resources are an essential component of our global collaborative network development strategy to connect healthcare and clinical research. Economies of scale and simple common sense demonstrate that sharing and integrating such resources saves industry, governments and regulatory agencies time and money. Projects using this innovative business model are already underway. This decision by ACRES allies to employ already established standards and networking technology platforms also promotes industry inter-operability and sustainability while minimizing IP liabilities and unnecessary risks and financial burdens, whether it involves sponsors, regulatory agencies, investigator sites, IRB’s, governments or other industry stakeholders.” Pacino added, “With a collaboratively-built, sharable system approach, we can ensure that creating efficiencies does not mean adding additional silos.”

Dr. Mitchell Efros, CEO of Verified Clinical Trials, a technology company focused on improving data quality and results by preventing dual enrollment in clinical trials, stated, “Verified Clinical Trials strongly believes that ACRES is the single best business model to help catalyze and ignite the necessary changes needed to provide long term and sustainable improvements in our research trials today and going forward.”

With intensified involvement of global expert industry leaders, ACRES continues to focus on enhancing long-term industry sustainability and facilitating the development of and access to new medicines through the creation of a global system for clinical research, built through the collaborative efforts of stakeholders throughout the entire healthcare and research endeavor.

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