The appointment of a senior management team for global operations and systems development is the latest milestone in the Alliance for Clinical Research Excellence and Safety’s (ACRES) efforts to build a global clinical research network based on standardisation, accreditation and a common information-technology platform.
Originally conceived in 2010 as a means to reshape the clinical research environment worldwide and enhance safety, quality and efficiency through a global initiative akin to the International Air Transport Association, ACRES has now created an Executive Office as it moves towards implementing a formal management structure. A Board of Directors will follow shortly.
Greg Koski, who is president and co-founder of the US-based non-profit organisation and former director of the Office for Human Research Protections at the Department of Health and Human Services, continues as ACRES president and as chief executive officer.Matt Whalen, principal at life-sciences consulting firm IMPACT LLC, takes on the role of chief operating officer at ACRES while Dennis La Croix, former vice-president, legal at Genzyme, steps in as general counsel.
Fellow co-founders Beat Widler, managing partner at Widler and Schiemann and former global head of quality for Hoffmann-La Roche, and Andrew Olmsted, vice-president of Research Dataware, become ACRES vice-president for quality management and vice-president for informatics respectively.
Brian Edwards, principal consultant at NDA Regulatory Science, is vice-president for safety and pharmacovigilance.
Honorio Silva, president of the Inter-American Foundation for Clinical Research and former vice-president for science and medical professional development at Pfizer, will “play a critical integrating role” as vice-president for professionalism and system development, ACRES noted.
“This is an important step for ACRES,” Koski said. “The personal commitments of such outstanding individuals to this effort speak to the importance and timeliness of the ACRES initiative and will position the organisation well to meet the challenges ahead.”
According to ACRES, its board of directors will include “internationally recognised and respected individuals who are visionary champions for innovation and integration in clinical research”.
Among the alliance’s ongoing programmes are:
• The Site Accreditation Standards Initiative (SASI). This is a collaborative effort to engage stakeholders and experts in clinical research and accreditation in developing comprehensive, uniform standards for use by third-party accrediting organisations worldwide, to ensure “professionalism and operational excellence” at clinical trial sites.
• The Site Optics and Quality Informatics (SOQI) initiative, which seeks to define research site-based performance metrics and system-wide informatics standards and functions that will ensure the interoperability of clinical-trial management systems within the ACRES Global Technology Network.
• Quality and safety initiatives focused on developing a common understanding of the quality drivers and human factors underlying process management and organisation in clinical research, while creating a platform for the controlled exchange of quality benchmark data to improve safety, quality and efficiency.