Home > Research Standards

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.

The Alliance for Clinical Research Excellence and Safety (ACRES) has endorsed the standard clinical trial agreement (CTA) template created by Model Agreements & Guidelines International (MAGI), striving to break one of the primary bottlenecks in research study startup, the contract negotiation process. In 2004, MAGI initiated a collaborative effort to create a CTA template that would be widely accepted, a significant challenge given the diversity of sponsors, sites and CROs in the industry.

"ACRES is all about like-minded, systems-focused organizations and people working together and leveraging the good work being done across the clinical research landscape. Our collaboration with MAGI is a good example, capitalizing on the valuable work done by this multi-stakeholder group over the past few years to create a tool set that benefits everyone. This is critical since every day of delay is a very costly impediment to the development and availability of new medicines," said ACRES CEO and co-founder, Greg Koski.

ACRES collaboration with MAGI is one of many bringing a collection of open-source tools to sites, CROs and sponsors to increase efficiency, promote standardization and facilitate the start-up process for clinical trials, all of which will result in significant savings in time and money while enhancing site productivity and sustainability, as well as quality. The clinical trials contracting process is challenging for all parties involved in the clinical research endeavor and a "master file" approach to establishing clinical trials agreements represents a significant advance over previous approaches.

In addition to creating the 11-page CTA template, MAGI has educated industry professionals about CTAs and certified Clinical Research Contract Professionals (CRCP).
“Real estate lawyers can negotiate $30-million transactions in three hours, while we spend three months negotiating $30,000 transactions. There is now a general consensus that the time for a standard CTA template has arrived. Other model CTA initiatives have recently emerged, which we welcome as part of the process of reaching an industry-wide consensus. We can agree to save lives,” added Norman Goldfarb, MAGI Chairman.

MAGI joins the growing list of nearly 200 organizations and individuals that are teaming up with ACRES and each other worldwide on diverse collaborations to improve the safety, quality, transparency and cost-effectiveness of the clinical research undertaking and to accelerate medicines development.

Despite a decade of numerous disruptive, innovative or transformative efforts attempted by the enterprise, serious challenges remain and progress has been limited by the failure to transparently connect and integrate these efforts. ACRES is working to overcome these limitations by providing an inter-connected, integrated, transparent, multi-stakeholder collaborative systems approach, and welcomes MAGI’s thoughtful and inclusive approach and innovative solutions.

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.”

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.

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."

© Copyright 2022 - ACRES - All Rights Reserved