Envision a world where all people have access to safe, effective, dependable and affordable medical treatment, medicines and devices–ACRES seeks to realize this vision by bringing together an alliance of stakeholders who share the belief that a high- performing global system for clinical research, a system focused on excellence and safety, is the key to achieving this shared goal.
To realizing this shared vision, many challenges must be addressed:
- The ineffectiveness and inefficiencies in the clinical research enterprise must be overcome
- Clinical research processes must be improved where they are most vulnerable from regulatory, business and ethical perspectives
- An expanded cadre of well qualified clinical investigators, research teams and sites must be developed around the globe
- A culture of safety and quality must be created to help rebuild trust in biomedical clinical research however and wherever conducted
- The utility of information technology and resources must be optimized
- And forces would need to be aligned to create an ecosystem responsive to the need for change, whether social, regulatory, economic or professional.
This is a tall order–ACRES Vision is at once simple to describe and yet quite challenging to implement–the answer to this lies in an approach that has worked in many other industries: a shared, collaborative global system for clinical research.
ACRES allies are committed to finding the most effective, innovative, ethical means of building, implementing and maintaining an integrated, comprehensive global system for clinical research, in a timely and cost-efficient manner–and then do it!
A system is a group of interacting, interrelated, or interdependent elements forming a complex whole that must work together to achieve a desired goal or outcome. This inter-dependence of components, so intrinsic to systems-thinking, has profound implications when building a global system for clinical research.
Specifically, no single organization can build the entire system because only the collective entirety of its parts possesses the information necessary to create a system that ensures the connectivity and interoperability of its components.
ACRES answer to this dilemma is simple–bring together all of the many stakeholders representing all of the “parts” of the clinical research endeavor and, through their shared expertise and collaboration, build a comprehensive, integrated system of clinical research together, one that serves the needs of and benefits all— this is ACRES mission.
Adopting an Alliance model, the Alliance for Clinical Research Excellence and Safety has therefore been connecting diverse stakeholders – including sponsors and CROs, government ministries and regulators, service providers, professional organizations, ethics committees, patients, and research sites – to collaborate on the building of the system.
Additionally, 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 incorporated.