The Alliance for Clinical Research Excellence and Safety (ACRES), a nonprofit multi-stakeholder collaborative building a shared global system to more effectively deliver promising new therapeutics, has launched a Global Stakeholder Consultation to better inform the development of standards, processes and policies to promote excellence and sustainability of clinical research sites worldwide.

The Global Consultation marks the beginning of the second phase of ACRES’ Site Accreditation Standards Initiative (SASI), which began with the convening of the SASI Project Steering Committee one year ago, chaired by Linda Meyerson, former CEO of global CRO Icon, and Tracy Blumenfeld of RapidTrials, a site-management organization.

The consultation will include a series of surveys, interviews and face-to-face interactive meetings with stakeholders from all sectors of the clinical research enterprise over the next year. The surveys will be powered by ViS Research, a provider of online feasibility assessment technology. The resulting report will be widely shared with the global clinical research community.

The consultation will build on the committee’s first year of work, which will be discussed at the inaugural face-to-face meeting in San Diego in June. Additional meetings are anticipated in Latin America, Europe, Middle East, Africa and Asia in association with the development of ACRES regional coordinating centers. Working groups also will begin to develop standards for excellence in several domains: personnel, facilities, management, information technology, integrity and recruitment.

“Interest in developing standards and processes to identify and reward outstanding research sites has intensified dramatically since the ACRES vision of a global network of accredited 'sites of excellence' was introduced three years ago,” said Blumenfeld. “This global consultation seeks the views of all stakeholders, so that we can build a system that benefits all stakeholders.”

“Through its many strategic allies, ACRES now can access more than 60,000 research sites worldwide, as well as patient groups, CROs, pharmaceutical companies and regulatory agencies, to ensure that the voices of all stakeholders are heard, understood and implemented for the benefit of all,” said Johan Karlberg, ACRES vice president for site development and support. “The industry finally is recognizing the critical importance of high-performing, professional sites, and we must build a system encompassing standards, tools and metrics to appropriately recognize, support and reward them.”

ACRES also announced Essex Management will be a strategic consulting ally to help facilitate the development of the ACRES Global Network of high-performing sites. Essex currently provides consulting and project management support for two of ACRES foundation initiatives including SASI, as well as supports development of a shared technology platform through the ACRES Site Optics and Quality Informatics (SOQI) project. Essex will help define the vision, scope and a tactical approach to successfully realizing the ACRES’s vision of qualification and accreditation for a global network of high-performing clinical research sites.

David Loose, Essex partner and vice president, said, “The ACRES initiatives address critical needs across the entire clinical research domain through a multi-stakeholder collaboration of the willing. It provides the foundation for a more efficient and sustainable clinical research enterprise, resulting in faster patient access to better and safer medical treatments.”