ACRES announced Phase 3 of its Site Accreditation and Standards Initiative
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, announced Phase 3 of its Site Accreditation and Standards Initiative (SASI). The third phase of the project 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 Global Standards Excellence (GSE) Working Party will be responsible for coordinating and integrating the standards development process. ACRES ally, Essex Management, will provide project support. 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 the 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.
Read the full release here.
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.