News
SCOPE Summit 2026 Panel Discussion: Diversity in Clinical Trials—What’s Working, What’s Next | Applied Clinical Trials Online
1+ hour, 33+ min ago (576+ words) Industry leaders emphasized that accelerating clinical research must go hand in hand with sustained, community-driven strategies to advance diversity, equity, and inclusion in clinical trials. "Scientific excellence depends on making sure that the people who are most in need of…...
SCOPE Summit 2026 Keynote Fireside Chat: Aligning Purpose, Innovation, and Operational Excellence in Clinical Development | Applied Clinical Trials Online
5+ hour, 54+ min ago (677+ words) Ken Getz of Tufts CSDD and Eliav Barr of Merck discuss how efficiency, public trust, and AI all fit into the current state of clinical research. The first full day of SCOPE Summit 2026 kicked off with a keynote fireside chat…...
SCOPE Summit 2026 Keynote Panel: Is Radical Acceleration in Clinical Research Possible? | Applied Clinical Trials Online
21+ hour, 40+ min ago (487+ words) Industry leaders explore areas of opportunity for acceleration as well as how early-phase planning, technology, and collaboration can keep moving the clinical ecosystem forward. Efficiency and accelerating clinical trial timelines have emerged as key themes at this year's annual SCOPE…...
Meeting Halfway: Co-Developing Frameworks for Seamless FSO to FSP Transitions
2+ day, 10+ hour ago (1043+ words) As clinical trials grow increasingly complex, the biopharmaceutical research industry faces a number of unprecedented pressures that are shifting the way outsourcing models are deployed. Sponsors are confronting macroeconomic headwinds: increased demand to accelerate cycle times, mounting cost pressures, and…...
ACT Brief: FDA Capacity Strains Timelines, Sponsors Rethink Site Support, and Regulators Align on AI
6+ day, 7+ hour ago (280+ words) ACT Brief: FDA Capacity Strains Timelines, Sponsors Rethink Site Support, and Regulators Align on AI'Applied Clinical Trials Online This is the Applied Clinical Trials Brief'your fast track to the latest insights shaping clinical operations and drug development. In a new…...
FDA Staffing Constraints Extend Planning and Review Timelines
6+ day, 21+ hour ago (309+ words) Charlie Paterson, partner at PA Consulting, explains how reduced FDA capacity and staff turnover have led to longer regulatory timelines, increased preparation for agency interactions, and delayed feedback during early trial planning. Editor's note: This transcript is a lightly edited…...
ACT Brief: RWE Refines Trial Design, Oncology CRO Scale Expands, and Feasibility Pressures Persist
1+ week, 7+ hour ago (298+ words) ACT Brief: RWE Refines Trial Design, Oncology CRO Scale Expands, and Feasibility Pressures Persist'Applied Clinical Trials Online This is the Applied Clinical Trials Brief'your fast track to the latest insights shaping clinical operations and drug development. In the final part…...
FDA and EMA Align on Ten Principles to Guide Artificial Intelligence Use in Drug Development
1+ week, 9+ hour ago (533+ words) The FDA and EMA have aligned on ten guiding principles for the responsible use of artificial intelligence across the drug development lifecycle, establishing a shared framework to support innovation, regulatory consistency, and patient safety. "Regulators have been very clear in…...
ACT Brief: Decentralized Innovation Faces Reality, RWE Finds Its Lane, and Clinical Ops Reset for 2026
1+ week, 2+ day ago (265+ words) ACT Brief: Decentralized Innovation Faces Reality, RWE Finds Its Lane, and Clinical Ops Reset for 2026Applied Clinical Trials Online This is the Applied Clinical Trials Brief'your fast track to the latest insights shaping clinical operations and drug development. In a new…...
ACT Brief: De-Identified Data Expands Trial Design, Global Production Normalizes, and FDA Updates Quality Framework
1+ week, 2+ day ago (261+ words) ACT Brief: De-Identified Data Expands Trial Design, Global Production Normalizes, and FDA Updates Quality Framework'Applied Clinical Trials Online This is the Applied Clinical Trials Brief'your fast track to the latest insights shaping clinical operations and drug development. In part two…...