Science 37 Metasite™ Undergoes Successful FDA Inspection, Marking Major Milestone in Virtual Site Quality Assurance and Compliance
13 5월 2024 - 9:00PM
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 37PR@science37.com
Science 37 (NASDAQ:SNCE)
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Science 37 (NASDAQ:SNCE)
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부터 11월(11) 2023 으로 11월(11) 2024