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.
As the ACRES organization continues to expand, it will 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 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.
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.