The Alliance for Clinical Research Excellence and Safety (ACRES) announced today that the National Academy of Medicine will host a special systems event, SYNERGY 2022, to convene at the National Academies of Sciences, Engineering and Medicine on December 12-13, 2022 in Washington, DC.
BOSTON (PRWEB) NOVEMBER 01, 2022
SYNERGY 2022 is the third event in a series of ‘systems-thinking’ exercises convened by ACRES since its founding in 2012, and the most ambitious to date. Together with its partner organizations, the MITRE Corporation and FasterCures, ACRES is bringing together a select group of 60 leaders and innovators from health, business, government, technology, academia, and patient groups to apply systems-thinking and systems engineering principles to envision a new integrated approach to health and science in the US. Our goal is to create a truly enterprise-wide system that uses advanced technologies and analytics to achieve levels of quality, safety, efficiency, and effectiveness that have not previously been possible in health and science.
“Many realized from their COVID-19 pandemic experiences that our present approach to health and science in this country remains fragmented, inefficient, and dysfunctional—we talk about a ‘healthcare system’ but we are far from that goal,” said Greg Koski, PhD, MD, ACRES President, and Founder. “While there are enterprises with successful systems, such as international air transport and banking, we have been unable to similarly apply systems-thinking and design to our health-science enterprise—and the result is a disconnected, inefficient, and extremely expensive endeavor that fails to provide optimal care and benefits to patients. We can and must do better.”
Dr. Michael McGinnis, the Leonard D. Schaeffer Executive Director of the National Academy of Medicine, expressed support for SYNERGY 2022’s focus on better integrating the generation of scientific evidence and insights from health and health care activities, saying “The National Academy’s Learning Health System Initiative has been working to facilitate the alignment of science, informatics, incentives, and culture to accelerate progress. The vision is now clearer, but advances in practical execution depend up on the sorts of discussions anticipated at SYNERGY 2022.”
ACRES’ SYNERGY 2022 non-profit partners, the MITRE Corporation of McLean, VA, and FasterCures, a center of the Milken Institute of Santa Monica, CA, are also two highly respected advocates for improving our nation’s health.
MITRE is committed to applying systems-thinking across government, industry, and academia to solve major national challenges, particularly accelerating the application of advanced technologies for enduring impact. MITRE currently operates several federally-funded research and development centers (FFRDC’s) for a variety of federal agencies, including the Department of Health and Human Services and the Center for Medicare and Medicaid Services. MITRE is a key sponsor for the SYNERGY 2022 event. MITRE Vice-President, Kimberly Warren, who holds a Master’s of Science degree in artificial intelligence, also heads the CMS Alliance to Modernize Healthcare FFRDC and is assisting in planning the event. “We believe that bringing together government, non-profits, academia, and industry can achieve data-driven innovation in healthcare, public and population health, and real benefit for patients. We are honored to be a partner in making this event happen,” said Warren.
Similarly, Esther Krofah, MPP, Executive Director for Health at the Milken Institute brings to SYNERGY 2022 her extensive experience in fostering collaborations among diverse stakeholders to address critical challenges and shared goals that improve the lives of patients. “This event comes at a time when many are motivated to approach ‘health-for-all’ in a smarter, more effective manner. FasterCures applauds ACRES’s vision and initiative in convening this event and we are excited to be part of it,” said Krofah.
SYNERGY 2022’s two-day working exercise in systems thinking seeks to envision and draft a blueprint for an “Intelligent HealthScience System”. Such a system, which combines human ingenuity with advanced technologies such as machine learning and artificial intelligence, can effectively provide analysis and feedback from multiple sources—whether patient data and outcomes, real world evidence, genomics, pharmacology, adverse events, or costs—enabling providers to deliver optimal precision care at a personalized level for every patient in an efficient and equitable manner. A full report of the proceedings will be published after the event.
Koski added, “The National Academy of Medicine’s 2001 landmark report “Crossing the Quality Chasm” called for a new patient-centered health system for the 21st century and laid out parameters for achieving it. Our challenge now is to co-design a system that will deliver on that promise, and that is precisely what SYNERGY 2022 intends to do.”
ACRES, The National Academy of Medicine, MITRE Corporation, and The Milken Institute are 501(c)(3) non-profit organizations operating in the public interest. For additional information, please contact Mary F. Tobin, PhD at mtobin(at)acresglobal(dot)net.
The Alliance for Clinical Research Excellence and Safety (ACRES), a US-based non-profit global collaborative working to improve medicines development and safety through the application of systems thinking, announced today that Ms. Pamela Duffy, an experienced 25-year Pfizer veteran with extensive background in systems development and deployment, has been tapped to chair its Board of Directors. Ms. Duffy’s appointment comes as ACRES is developing a strategic plan for its second decade of system-building initiatives in clinical research and medicines development.
ACRES President and co-founder, Dr. Greg Koski, expressed ACRES excitement about Ms. Duffy’s appointment, noting that “Pam Duffy has been a kindred spirit for several years, and she now brings to ACRES exceptional thoughtfulness and experience in technology-based clinical systems and patient engagement,” noting her recent involvement in Pfizer’s pivotal Covid-19 vaccine trials.
Ms. Duffy is a Senior Director, IT Lead for Clinical Development & Operations & Experience at Pfizer based in Groton, Connecticut. She assumes the chair from Koski, who recently stepped down from his roles as Chair of the ACRES Board of Directors and Chief Executive Officer. “Every organization must periodically re-vitalize its vision and leadership and, for ACRES, that time has come. In her new role as Chair of the Board of Directors, Ms. Duffy will lead an effort to envision the future direction and format of the organization for its second decade.”
Duffy brings to ACRES her passion for helping people and organizations. “What we do is ultimately about improving the quality of life for everyone in the healthcare and medicines development ecosystem, especially patients. More effective use of technology, along with a systems approach, is essential to making a meaningful difference,” said Duffy.
Duffy and Koski indicated that the ACRES Strategic Planning Initiative is progressing well, driven in part by lessons learned during the Covid-19 pandemic. “We envision a future which integrates health care and health sciences, what we call an Intelligent HealthScience System. It will provide information from analysis of multiple data sources—health records, clinical research, natural histories, real world evidence—as well as enhanced mechanisms for collaboration across medical and research environments,” said Koski. “We want to be certain that our organization is optimally structured and has the right leadership to be effective in pursuing and refining our mission,” added Duffy. ACRES is currently leading multi-stakeholder initiatives in technology, pharmacovigilance and safety, and patient empowerment through improved systems approaches.
Koski also took the opportunity of Duffy’s appointment to thank the members of the ACRES Board of Directors and Executive Office for their continuing support and to gratefully acknowledge the contributions made over the years by retiring board members, including Briggs Morrison, Badhri Srinivasan and Brendan Buckley. “ACRES has benefited enormously from their insights over the years, and we wish them well.”
Morrison now is board chair at the Site Accreditation and Standards Institute, an autonomous non-profit entity spun-off from ACRES to operate an independent global accreditation process for clinical research sites, based upon the quality standard developed by ACRES.
“ACRES visionary systems-building efforts are more important today and for the future than ever before,” said Duffy. “I am thrilled to be part of this team and look forward to working with the Board of Directors and the Executive Team to define what ACRES and its allies will do in the next ten years.”
The Alliance for Clinical Research Excellence and Safety (ACRES), a Massachusetts-based global non-profit collaborative, is distributing a simple online tool for collection and analysis of real world data on predisposing conditions, treatment strategies, outcomes and side effects experienced by COVID-19 patients. This survey tool, designed by Veracuity LLC, expands data collection from providers and hospitals in near-real time to enhance understanding of the COVID-19 pandemic, including risk-factor identification, triage, treatment management and outcome predictors to gain insight into the safety and efficacy of traditional, experimental and off-label therapies.
The authors of the survey tool are Veronika Valdova, DVM, Jonathan Fishbein, MD and Sreeram Penna, MBBS, MRCS, of Veracuity LLC, a Pennsylvania-based biopharmaceutical safety informatics and analytics firm. According to Dr Valdova, “Our survey tool was designed with the care providers in mind, to make it as easy as possible to capture the value of their front-line experience to better inform our efforts to confront this viral pandemic.”
ACRES, which uses systems approaches to improve health science and medicines development, has implemented the tool, publishing the link to it on its website. Dr Greg Koski, President and CEO of ACRES said, “In a time of crisis like this, the information that can be gleaned from real world experience can help us find our way, to ask the right questions, and learn from experience—not to replace science, but to better inform its pursuit.”
Already validated by a focus group of physicians actively caring for COVID-19 patients, the survey can be completed quickly by healthcare professionals as it requires minimal text entry and uses well-established rating scales that are routinely used in clinical practice.
The survey tool captures real-world data to generate evidence to address the most pressing knowledge gaps relating to the treatment of patients affected by COVID-19, such as:
Data will be securely processed and stored by Veracuity LLC, utilizing the eVERATM, platform and the results shared gratis with the medical and scientific community. Interactive visuals based on collected data, as designed and developed by the Veracuity team, will be displayed on the ACRES website.
Currently, there are no medications approved for the causal treatment of COVID-19. Hospital interventions consist of supportive care and off-label administration of medicines approved for different conditions and experimental products. Additionally, the precise mechanism of action of many therapeutic options (e.g. hydroxychloroquine, ivermectin or azathioprine) against SARS-CoV-2 is often unclear.
As a result, all COVID-19 patients are, in fact, subject to innovative and sometimes unproven therapeutic approaches. In the absence of evidence from randomized controlled trials, it is imperative to gain insight into treatment effectiveness from real-world experience to enable rapid adjustment of clinical protocols as more data becomes available. At the same time, for the sake of patient safety, it is essential to improve clinical care and to understand the harmful effects of drugs in specific clinical scenarios as early as possible to avoid potential harm: Primum non nocere (first, do no harm).
The web-based tool is widely available through ACRES global network. The target audience for the survey are teams caring for COVID-19 patients. Caregivers are encouraged to complete the survey on their patients with COVID-19 upon case closure, i.e. discharge from hospital or death.
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.
Dr. Greg Koski, President and CEO of the Alliance for Clinical Research Excellence and Safety (ACRES), announced today the roll-out of the ACRES Patient Empowerment Initiative, aligning diverse stakeholders across the clinical research community—including patients, regulators, pharmaceutical companies, research sites, contract research organizations, suppliers, ethics committees—to integrate multiple efforts currently being conducted to bring the patient voice to clinical research.
Patient centered research has become a core issue for all in healthcare and clinical research but the achievement of this goal has been hampered in part by the large number of stakeholders, with often competing interests, in the research enterprise, leading to isolated patient programs with limited impact. Another issue has resulted from historically not viewing patients as equal participants in the research process, seeing them just as research subjects rather than as co-creators in research.
ACRES, an alliance-based non-profit organization operating in the public interest, is dedicated to building a comprehensive, integrated global system for clinical research. As such, it works to bridge and unify improvement efforts of various stakeholders striving to enhance quality, safety, integrity and operational effectiveness of biomedical product development and health research.
In announcing this initiative, which has been under development for nearly two years, Koski explained that “patients are at the core of these efforts. The Patient Empowerment Initiative is intended to provide a “home” for multi-stakeholder sharing of concerns, experiences and challenges encountered in patient engagement, as well as the design and pilot-testing of best practices and other tools that serve both patients and all other clinical research stakeholders.”
ACRES systems approaches lay the foundation for a comprehensive, integrated approach to patient engagement. ACRES will roll out this patient initiative in the 1st Quarter 2018, with an all-stakeholder Steering Committee, including strong patient representation, which will establish and prioritize topics for discussion and action. Based upon these recommendations, Working Groups will be established by 2nd Quarter 2018.
Dr. Mary F. Tobin, Special Advisor to the President and CEO, will serve as the ACRES liaison to the PEI. “When we first started this effort, we thought it would be straightforward. We soon learned that patient engagement means very different things to different stakeholders, and that understanding a variety of world views would be essential”, said Dr. Tobin. “This is not about getting more patients to enroll in clinical trials. It is about understanding how we can more effectively empower patients to engage meaningfully in every part of this critically important endeavor.”
Dr. Tobin created the original vision of this initiative with the help of the late Jack Whelan, a remarkable patient and research advocate who fought fearlessly for patients, and Dr. Dawn Richards, a tireless Canadian patient advocate working with Clinical Trials Ontario. Additional ideas and support have been provided by Maya Zlatanova, CEO of FindMeCure, based in the United Kingdom.
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.
Dr. Greg Koski, CEO and Co-Founder of the Alliance for Clinical Research Excellence and Safety (ACRES), received a Lifetime Achievement Award during a special plenary session of the Partnerships in Clinical Trials (PCT) Europe conference at the RAI Center in Amsterdam.
The PCT Lifetime Achievement Award, in association with mdgroup, a United Kingdom-based clinical trial services group, recognizes individuals who have changed the direction of the clinical trials world, leaving a legacy and making a major impact on this endeavor over their careers.
Chosen by a panel of experienced industry professionals, the prestigious award is presented at the Partnerships in Clinical Trials Europe event run by KNect365 Life Sciences.
Now in its third year, previous awards went to Jean Edwards, Procurement Director for Europe, Australia & Japan at Eli Lilly, in 2016. In 2015, Professor Ken Getz took the inaugural prize for his work as Director and Associate Professor at Tufts Center for the Study of Drug Development.
Koski received the award based on his extensive clinical and basic biological research in addition to his contributions in the areas of research ethics, regulation, professionalism and clinical trials operations. Other finalists for this year’s award included Dr. Steven Anderson, SCO at Covance, USA; Estrella Garcia, Director Global Clinical Operations, R&D at Almirall, Spain; and Patricia Leuchten, Founder and CEO at The Avoca Group, USA.
Throughout his career, Koski has worked to develop processes and programs that promote responsible, ethical professional conduct, based on principles of total quality management and systems thinking.
Koski is an Associate Professor at Harvard Medical School, Honorary Anesthetist at the Massachusetts General Hospital and a founding member of the Partners HealthCare System. After more than 30 years as a member of the MGH Cardiac Anesthesia Group--and 50 years at Harvard University--Koski set aside his clinical, research and teaching responsibilities in 2015 to devote himself full-time to his leadership responsibilities at the Alliance for Clinical Research Excellence and Safety (ACRES), a global non-profit multi-sector collaborative building a shared integrated system to accelerate innovation and medicines development.
One major focus of ACRES ongoing system-focused initiatives is the creation of global standards and processes for accreditation of clinical research sites. This transformative effort, being conducted in partnership with BSI (British Standards Institution), is targeted for implementation in 2019. ACRES currently engages some 140 strategic allies and partners worldwide in its systems-building initiatives.
“This recognition is a great honor, but it rightfully belongs to our many colleagues who are making ACRES happen--we have much yet to do and we must never forget that millions of patients are waiting and it is why we do what we do”, said Koski in accepting the award.
Koski dedicated the award to the memory of Jack Whalen, a clinical research and patient empowerment champion who co-chaired the ACRES Patient Engagement Initiative. “Jack Whalen’s time ran out—we lost him just before Thanksgiving after a courageous and inspiring battle against cancer that included a worldwide crusade in support of broader patient engagement in clinical trials at all levels. We will miss him, but his spirit and commitment will continue to inspire us all to do more”.
In addition to his academic career, Koski served as the Director of Human Research Affairs at both the MGH and Partners before being recruited by former Secretary of the US Department of Health and Human Services, Donna Shalala, to be the first director of the Office for Human Research Protections (OHRP) in 2000.
He participated in numerous international initiatives including the WHO/TDR Strategic Initiative for Developing Capacity for Ethical Review, the WMA revisions to the Declaration of Helsinki and the development of standards for competency-based education, training and certification of pharmaceutical professionals, including clinical investigators.
His service on boards for professional organizations include the Association of Clinical Research Professionals, the Association of Pharmaceutical Physicians and Investigators, and the SAFE Biopharma Association. He received special recognition awards from Public Responsibility in Medicine and Research (PRIM&R) and the USDHHS. Earlier this year, Koski was named to the PharmaVoice 100 list of the most inspiring individuals in the health sciences.
Task Force Dagger Foundation (TFD) Managing Director, Keith David, and the Alliance for Clinical Research Excellence and Safety (ACRES) President and CEO, Greg Koski announced today that their non-profit charitable organizations have established a strategic alliance to address the grave health challenges impacting America’s elite special operations forces and their families through application of ACRES systems-based approaches to accelerate research and advance integrated care.
Task Force Dagger, drawn from units of the United States Special Operations Command USSOCOM, was the designation of the Special Forces elements that conducted the initial invasion of Afghanistan following the terrorist attack on the United States on September 11th, 2001.
Founded in 2009, the Task Force Dagger Foundation provides assistance not covered by the Military, DOD, VA, or their insurance to wounded, ill, or injured US Special Operations Command (USSOCOM) members and their families, responding to urgent needs and providing next-generation health solutions for issues facing our service members, particularly in the areas of Traumatic Brain Injury (TBI), Post-Traumatic Stress (PTS), and environmental exposures.
To date, Task Force Dagger Foundation has supported the US Special Operations Command with approximately $3.4M in support to over 1,600 families. The Foundation‘s Special Operations Forces (SOF) Health Initiatives Program takes a comprehensive systems biology approach known as Functional Medicine including advanced functional diagnostic health assessments such as biochemical and metabolic analysis, neuroendocrine testing, genetic testing and extensive diagnostic testing for occupational and environmental exposures such as heavy metals and other deployment related exposures.
The SOF Health Initiatives Program offers a comprehensive patient-centric systems approach to resolving health complaints and creates an environment conducive to healing and recovery based on each individual’s biochemical individuality and genetic uniqueness.
Under their alliance agreement, ACRES, a multi-stakeholder collaborative committed to accelerating clinical research and medicines development in the public interest, will apply the integrated systems model developed for the Moonshot on Cancer to the functional medicine paradigm adopted by the Task Force Dagger Foundation.
The SOF Health Initiatives Program has teamed up with multiple organizations such as the Cleveland Clinic Center for Functional Medicine, EXOS, Millennium Health TBI, The Brain Treatment Center (USC), CERESCAN, InLight Wellness and the Elk Institute to offer a complete start to finish program that merges and optimizes health and wellness.
ACRES Chief Technology Officer and Board member, Bob Stewart, and Geoffrey Dardia, Founding Director of the SOF Health Initiatives Program, masterminded the creation of the strategic alliance.
“ACRES people-focused, technology- supported model is based upon a coalition of major academic, government and private-sector organizations across the healthcare, clinical research and the medicines development domains. It is ideally suited and immediately applicable to the needs and goals of the Task Force Dagger Foundation’s SOF Health Initiatives and will help our special forces who sacrifice so much for us all. We are thrilled to be involved in this effort,” said Stewart.
Keith David shared Stewart’s enthusiasm. “We at the Task Force Dagger Foundation are pleased to partner with ACRES and work together to research, find, and provide solutions to issues faced by many of our service members, veterans, and their families. Our service members and their families are affected by the environmental and occupational hazards they encounter every day in the defense of our country. We must find the root causes of the illnesses, treat patients, and not merely manage diseases. We look forward to working with ACRES to be part of the solution for our brave warriors their families and collaboratively spread these solutions to all.”
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.
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.