Science 37 Metasite™ Undergoes Successful FDA Inspection, Marking Major Milestone in Virtual Site Quality Assurance and Compliance
Science 37 Holdings, Inc. announced the successful outcome of its recent FDA inspection for the Science 37 Metasite™ virtual site model, focusing on critical areas like data integrity, subject safety, and Principal Investigator oversight. The inspection, conducted between February 26 and March 6, 2024, resulted in no significant issues identified, showcasing Science 37’s commitment to regulatory compliance and quality research. This milestone underscores Science 37’s ability to provide high-quality, compliant data and accelerate clinical research.
Successful FDA inspection with no significant issues identified
No objectionable conditions or practices identified during closing meeting
Positive impression left on FDA inspectors by Science 37’s decentralized clinical site model
Commitment to regulatory compliance and quality research demonstrated
Ability to provide high-quality, compliant data and accelerate clinical research
- None.
Science 37’s Virtual Site Model for Clinical Research Impresses in First-of-its-Kind FDA Inspection
RESEARCH TRIANGLE PARK, N.C., May 13, 2024 (GLOBE NEWSWIRE) -- Science 37 Holdings, Inc. today 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.
To learn more about the Science 37 Metasite™, please visit www.science37.com.
About Science 37
Science 37’s mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; the Metasite™ and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by a proprietary technology stack with in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. To learn more, visit www.science37.com, or email science37@science37.com.
To view studies that Science 37 is actively recruiting for, please visit https://studies.science37.com/current-studies/.
Media Inquiries
Science 37
PR@science37.com
FAQ
<p>What was the focus of the recent FDA inspection conducted by Science 37?</p>
The recent FDA inspection focused on critical areas such as data integrity, subject safety, and Principal Investigator oversight.
<p>When was the FDA inspection conducted by Science 37?</p>
The FDA inspection was conducted between February 26 and March 6, 2024.
<p>What was the outcome of the FDA inspection for the Science 37 Metasite™ virtual site model?</p>
The outcome of the FDA inspection was successful, with no significant issues identified and no objectionable conditions or practices noted during the closing meeting.
<p>Who led Science 37’s internal Quality Assurance & Compliance team during the FDA inspection?</p>
The internal Quality Assurance & Compliance team was led by Irena Lambridis, VP, Head of Quality Assurance & Compliance at Science 37.
<p>What is the Science 37 Metasite™ and what does it aim to achieve?</p>
The Science 37 Metasite™ is a Virtual Site that allows universal trial access for patients, enabling them to participate in clinical trials from their homes or local community providers. It aims to accelerate clinical research and increase patient diversity in trials.
