ACRES Global Framework
ACRES Organizational Model
As the drug development enterprise seeks new models to reduce costs, time, and unethical behavior while improving quality, efficiency, and safety, a systems approach that aligns appropriate incentives with desired outcomes offers great opportunity for the biomedical R&D enterprise.
A successful systems approach recognizes that individual elements of any enterprise are interconnected and cannot effectively operate in isolation – in clinical research, whether one is considering sites, clinical trial management systems, unified safety databases, regulatory oversight or public outreach, all components must work together to achieve the desired outcome.
Since no one organization can construct a system for clinical research that is comprehensive, shared and integrated, the Alliance for Clinical Research Excellence and Safety has been connecting diverse stakeholders – including sponsors and CROs, government ministries and regulators, service providers, professional organizations, ethics committees, patients, and research sites – to build the system collaboratively.
In the current world of clinical research, any system must also be global. Clinical trials are conducted worldwide and many different regulatory bodies, ethics committees, demographic challenges, and medical care as well as cultural values regarding safety, quality, and transparency must be accommodated.
Such cooperative and global work does not happen by accident. The organizational structure of ACRES reflects this need to provide both a “home” for the necessary alliances, initiatives and collaborations as well as the focused, visionary leadership to make it happen.
The ACRES organization is comprised of:
- ACRES Global, which houses the ACRES Executive Office,
- ACRES Regional Coordinating Centers, which are outreach extensions of ACRES Global
- National Affiliate Organizations, which are linked to a regional coordinating center but are separate entities following the rules of the host country
- Global Network Sites, where trials are actually conducted
ACRES Global and Executive Office receive advice and support from the more than 90 executives, senior managers, and subject matter experts engaged in ACRES, from the leadership of 46 non-profit and for-profit organizations that are ACRES Strategic Allies, and from individuals serving on the ACRES Foundation Initiative Project Steering Committees, Global Advisory Board, Regional Coordinators Council, Board of Directors, and Executive Office. These individuals have contributed significantly toward establishing ACRES’ multi-stakeholder acceptance. They are dedicated to ACRES mission and specific goals, offering international visibility, multi-sector experience, and social entrepreneurial leadership, experience, knowledge, and commitment.
Regional Coordinating Centers extend ACRES presence globally to support ACRES mission and vision, including the Global Network of Sites and Platform of Technology and Services.
Underpinning the Centers are Co-Development Agreements (CDAs) with independent, non-profit entities wherever they may exist and developed in cooperation with ACRES Global. Currently, they are being developed in Europe, Asia, and Latin America.
ACRES Regional Coordinators, based in the regions they represent, are appointed by ACRES to facilitate relationships with those entities having CDAs with ACRES. Together, the Coordinators make up the ACRES Regional Coordination Council.
Regions, using demarcations defined by the WHO, with Regional Coordinators include:
- African Region
- Region of the Americas
- South East Asia Region (includes Bangladesh, India, Indonesia, Thailand)
- European Region
- Eastern Mediterranean Region
- Western Pacific Region (includes Australia, China, Japan, Hong Kong, Korea, Singapore)
ACRES Executive Office
ACRES Executive Office members are based around the world, with the home office located in Cambridge, Massachusetts, U. S. A. The corporate culture of ACRES mirrors that of its Alliance model wherein members of the Executive Office are a collaborative group working closely together. The Executive Office members share responsibility for the ACRES initiatives and may co-chair the various 90+ member Project Steering Committees that are doing the work necessary to build ACRES Global System for clinical research. They also frequently serve as conduits for the discussions and deliberations that precede the now 45+ Strategic Alliances under ACRES umbrella.
In addition, the members of ACRES Board of Directors, Advisory Board and Global Steering Committee play a significant role in the work of ACRES EO members, representing and mediating between ACRES Executive Office members and the larger world of clinical research stakeholders. Eliciting the advice and recommendations of these groups form a continual feedback mechanism for the members of the Executive Office in directing the work of ACRES.
ACRES Regional Coordinating Centers
ACRES Regional Coordinating Centers (RCCs) are the link from ACRES Global to the rest of the globe. Regional Centers, as outposts of ACRES, and their Coordinators promote ACRES’ mission and deliverables, in part by interacting with the professional associations, academic institutions, and clinical research sponsors, regulatory agencies, government and other stakeholders in each region.
Developing the strategy, plan, and implementation of the ACRES’ Global Network in the respective jurisdiction, the RCC offices lead the ACRES’ outreach effort to regional and country investigators and sites, offering the necessary information to register in the ACRES’ Global Network.
An important role of RCCs is to further facilitate ACRES presence at the country level, identifying local advisors and groups to help in advancing ACRES’ vision and mission as well as to identify candidates who might become national coordinators where needed. RCCs ensure the convergence and alignment of local initiatives with ACRES, particularly as related to site accreditation, qualification, and certification of the clinical research team.
ACRES Regional Coordinating Centers
National Affiliate Organizations
National Affiliates, set up by host country organizations, promote the goal of accreditation, qualification, and certification according to globally-acceptable standards as key elements to ensure the quality, safety, and ethical conduct of trials and they develop the mechanisms to ensure continued communication to address site-specific needs toward achieving these goals according to globally-acceptable standards.
National Affiliates also create mechanisms to facilitate appropriate contact between ACRES and the local academic institutions, regulatory agencies, and professional associations and they identify opportunities to further develop ACRES-related Initiatives.
To start, ACRES has initially targeted 21 countries, identified by ACRES research and in consultation with a number of global experts.
Covering approximately 80 % of the overall site universe are Brazil, Colombia, Peru, Japan, Korea, China, India, Australia, Germany, France, UK, Spain and Italy, in addition to North America (Mexico, Canada, USA)
In addition are Turkey, Malaysia, Pakistan, Bangladesh, and Russia, countries where ACRES has strongly established relationships with individuals who can serve as Coordinators.
Prospective ACRES Japan Connections Model
Clinical Research Sites
ACRES is building the foundation for a global network of accredited, sustainable research sites supported by a robust information technology platform to ensure safety and continuous monitoring while improving performance and efficiency.
When fully developed, the ACRES Global Network will consist of thousands of independent, sustainable, fully-accredited clinical research sites, each with rigorously trained and certified professional research team and facilities so that they can be trusted in their communities and by their global partners to properly conduct clinical trials in a scientifically and socially-responsible manner ensuring uniform quality, safety and integrity. The sites will be supported by a robust, interactive information technology platform to provide inter-connectivity and data regarding safety, performance and quality.
This “neural net” and shared data-warehouse will enable real-time capture of important operational, quality, and safety data at the point of origin and facilitate sharing of critical, non-proprietary information for closed-loop coordination and monitoring of the system performance on a continuous basis with feedback to support ongoing total quality management and pharmacovigilance.
ACRES organizational philosophy, which positively aligns ethics, scientific integrity and good business practices and provides appropriate opportunities and incentives to further the mission of therapeutic development in a safer, scientifically sound, and socially responsible manner that rewards all participants and stakeholders, guides the development of the Global Network of Sites.
ACRES Vision for Global Network Clinical Research Sites in Japan