Science 37 Holdings, Inc. announced the preliminary outcome of its recent FDA Inspection focusing on critical areas and documentation. The nearly two-week review included, but was not limited to, the Science 37 Metasite™ model and internal processes, technology utilized to support each trial, data integrity, efficacy, subject safety, protocol deviations, collaboration across teams, and, most importantly, Principal Investigator oversight.
Conducted between February 26 and March 6, 2024, the first-of-its-kind FDA inspection yielded success with no significant issues identified (“No Action Indicated”) and no objectionable conditions or practices identified during the closing meeting. The inspection was hosted by Science 37’s internal Quality Assurance & Compliance team, led by Irena Lambridis, VP, Head of Quality Assurance & Compliance at Science 37. In addition to these findings, the inspectors noted Science 37’s knowledge and ability to articulate details outlining each project, and comprehensive responses to all questions with documentation as evidence when requested.
“This is likely the agency's first encounter with the fully decentralized clinical site model and we are proud that the nearly two weeks of inspections left them with a very positive impression. Working in a highly regulated environment, Science 37 prioritizes regulatory compliance and integrates quality into every part of its operations,” said Irena Lambridis. “This inspection is a demonstration of our daily commitment to doing high-quality, auditable, submission-level research, and being inspection ready at all times. Earning the confidence of FDA inspectors sends a powerful message to study sponsors and CROs in need of quality, compliant data and research acceleration,” she added.
The Science 37 Metasite™ is a Virtual Site that enables universal trial access for patients and expands the reach of clinical research beyond traditional sites. It allows patients to participate in clinical trials from the comfort of their own homes or at local community providers. The Metasite™ is powered by a proprietary technology platform and in-house medical and operational experts, which ensure uniform study orchestration, greater compliance, and high-quality data. It aims to accelerate clinical research and increase patient diversity in trials.