Global Standards Initiative for Clinical Research Sites Advances

The Alliance for Clinical Research Excellence and Safety (ACRES), a multi-stakeholder non-profit collaborative building a global system to enhance safety, quality and efficiency in clinical research, today announced Phase 3 of its Site Accreditation and Standards Initiative (SASI).

Amir H. Kalali, Vice-President, Global Head, Neuroscience Center of Excellence at Quintiles and Arti Bajpai, President, Compliance and Quality Integration (CQI) Consulting will lead the effort as co-chairs of a Global Standards for Excellence (GSE) Working Party that will include experts with expertise in all aspects of clinical research site management and operations, quality management, and regulatory oversight from around the world.

This effort builds upon the earlier work of the SASI Project Steering Committee, lead by Linda Meyerson, former COO of ICON, and Tracy Blumenfeld, President and CEO of RapidTrials. The Committee surveyed the current clinical research environment to identify key issues regarding site-standards, including common minimal requirements for research sites globally and potential performance and quality metrics. A report, describing the findings of this initial phase, is expected in late fall of 2014.

The second phase of the initiative, a series of global consultations with key stakeholders, began in June 2014 in San Diego and will continue over the next two years with consultations in Europe, Asia, Latin America, Africa and the Middle East. The consultations seek input from all clinical research stakeholders to ensure that the standards and process for accreditation of sites meets the needs and expectations of the various sectors.

The third phase of the project now begins formal development of standards and metrics for site accreditation. Teams of 5-7 experts drawn from the global stakeholder community will develop standards in at least seven domains: personnel, facilities, management, information systems, quality management, recruitment and enrollment, and research integrity. Additional cross-cutting teams in specialty areas, such as first-in-man studies and pediatrics will also contribute their expertise. The GSE Working Party will be responsible for coordinating and integrating the standards development process. ACRES ally, Essex Management, will provide project support.

Working Party co-chair, Arti Bajpai, brings more than 25 years of industry experience to her role. “We are looking to accomplish critical quality enhancing steps for clinical research. This initiative will drive cultural change within the investigative site through proactive and measurable quality steps and further establish Quality Management. I am thrilled to be a part of resolving this critical need for the patients. The goal is to make new, safe medicines available to patients more quickly with improved outcomes,” said Bajpai.

Anticipating a multi-tiered, phased implementation approach, levels of accreditation will be based on complexity, risk and specialization of the research protocols to be performed at any given research site. By leveraging existing guidelines, recommendations and qualification practices already developed by sponsors, CROs, site-management organizations, professional organizations and established site-networks, an initial draft of standards for review and comment is expected by early 2015, with initiation of pilot testing in mid-2015 and a first round of accreditation in early 2016.

Added Kalali, “Our long term vision is for a system of ‘dynamic accreditation’ that automatically captures and analyzes operational data to continuously monitor and improve site and system performance to benefit all stakeholders, including patients.”

Concurrently with the standards development, ACRES is working to establish a neutral, independent entity to house, manage and oversee the accreditation process. ACRES itself will not be an accrediting body. Accreditation of as many as 150,000 sites globally will require multiple accrediting entities, each of which will itself require accreditation to ensure the integrity and effectiveness of the accreditation process.

“We understand very well that an effective process and standards for site-accreditation must provide real value to all stakeholders—it must support efficient and effective systems processes without imposing needless burdens, either time or money,” noted ACRES President and CEO, Greg Koski. “At the same time, it must recognize and reward sites of excellence worldwide. The goal of this Alliance is to build a truly effective, shared system to safely and efficiently bring new medicines to the people of the world, and a global network of high-performing, sustainable sites is essential to this goal.”