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Active on improving trials
CAMBRIDGE, Mass.—The Alliance for Clinical Research Excellence and Safety (ACRES), a non-profit organization building a global system for clinical research, and ActivMed Practices & Research Inc., a woman-owned, for-profit, multispecialty, free-standing research organization, have created a strategic alliance to enhance clinical research site standards, accreditation and training, as well as community-based site development programs. The partnership aims to enhance the quality and sustainability of clinical research sites.
ActivMed will participate in ACRES’ ongoing Site Accreditation and Standards Initiative to improve performance of global research sites through shared standards, accreditation, training and support. ActivMed participation will start with membership in a Phase 3 standards domain team involving personnel and professionalism criteria.
ActivMed, which has access to nearly one million patients and a full range of clinical studies, will also collaborate with ACRES in the testing of developed standards and processes for ACRES site accreditation work. Other areas of shared interest include professional development programs for research staff that can be offered within local communities as well as online and the development of education and training programs.
“The creation of a systems-based approach to promote high-performing clinical research sites and to properly reward the work they do is long-overdue,” said Terry Stubbs, ActivMed founder, president and CEO. “The value proposition is clear: we believe this is a terrific opportunity for sites committed to quality, like ActivMed, to get involved and to have real impact.”
According to Greg Koski, ACRES co-founder and CEO, “We are delighted that a growing number of sites and site organizations worldwide are aligning with the ACRES vision. ActivMed is committed to quality in every dimension of its work in clinical research, and it now brings this commitment to this global collaboration.”
Stubbs had learned about ACRES at a presentation done by Koski during a MAGI conference. She “was excited about the industry changes that may be coming and how it would affect us at the site,” adding, “At sites, we know things need to change, but we have very little power to do so. Unless all players get on the same page about what works and what does not work, the industry will continue to waste money trying to do things the ‘old and broken way.’ Creating one system that can be used all over the world makes perfect sense.”
After attending another conference in Boston for ACRES, Stubbs decided that she wanted to be part of this new alliance and was willing to donate time and effort to help move things forward. She and Koski agreed that changes were needed and more people needed to be willing to donate time to move this imitative forward at a faster pace.
In terms of objectives, Dr. Mary Tobin, special advisor to the president and CEO of ACRES, explains, “With all ACRES strategic alliances, now approaching 100, there is an overall commitment to collaborate in building the global system to increase quality, accountability, safety and excellence in clinical research. Then, depending on the individual strategic alliance partner, engagement involves projects associated with one or more of ACRES' different initiatives.”
According to Tobin, ActivMed site work “falls naturally into ACRES sites initiative, which includes many aspects of site excellence, such as accreditation and standards and the global network of sites.” Because systems elements are always connected, elements of other initiatives “may cross over, such as quality assurance systems, global ethical and regulatory innovation, the development of a product safety culture or certainly patient engagement efforts, and underpinning all initiatives is the global technology platform,” she says.
“While other organizations may work with a few other stakeholders, none have brought together a comprehensive multistakeholder consortium focused on both a systems approach and a drive towards implementation. As a global non-profit operating in the public interest, ACRES is ideally positioned to facilitate cooperation among all of the stakeholders. ACRES began by envisioning a new future, and the alliance has risen to the challenge of creating it … this is an exciting time, and it will have dramatic impact for decades to come,” Tobin adds.
Stubbs wants to help create courses that can be offered at no cost or low cost to sites and proper training programs within local areas. She hopes to be changing systems so that staff can start work already knowing the ins and outs of research, instead of having to learn almost everything on the job.
Stubbs said, “We all have lots of years of experience working in the field of clinical research. Each ACRES ally comes with its own personal gifts of accumulated knowledge, depending on what area of research it works in. We can bring this knowledge to the table and share with each other. We can find what works and does not work and push the good ideas ahead to share with the industry. ACRES has created the largest and most representative alliance ever assembled in the name of strategic transformation of this endeavor. ACRES’ reach and focus is global, and its approach is inclusive and collaborative, one in which all stakeholders can take part and benefit.”
“Dramatic changes such as remote risk-based monitoring and auditing, real-time performance management, regulatory innovation and simplification will completely transform the way we do things today; everyone will benefit, and the world will become a healthier, more productive place for all,” Tobin concludes.