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MORRISVILLE, N.C. - Science 37, a provider of direct-to-patient clinical trial services, announced Wednesday it has successfully completed its third U.S. Food and Drug Administration (FDA) inspection with a No Action Indicated (NAI) recommendation. For detailed analysis of healthcare technology companies and their regulatory compliance track records, InvestingPro subscribers can access comprehensive industry metrics and expert insights.
The inspection, which evaluated the company’s role in a Phase 3 primary biliary cholangitis study, found no objectionable conditions and resulted in no Form 483 observations. Science 37 enrolled 47% of the U.S. study population for this registrational trial.
FDA officials reviewed the company’s internal processes, technology platforms, data integrity measures, patient safety protocols, and documentation during the inspection.
This marks Science 37’s third consecutive successful FDA inspection in less than two years, following similar NAI results in March 2024 and April 2025.
"Our team’s consistent track record not only validates the rigor of our model but also demonstrates how direct-to-patient research can expand reach, safeguard patient safety, and deliver data of the highest integrity," said Dr. Debra Weinstein, Chief Medical Officer at Science 37, according to the company’s press release.
Science 37’s Direct-to-Patient Site model allows clinical trial participants to engage in studies from their homes rather than traveling to traditional research sites. The company utilizes nationwide recruitment capabilities and maintains medical licensure across all 50 states to provide investigator oversight, research nursing, coordinator support, and logistics services.
The company states its approach helps accelerate enrollment while maintaining data quality across various types of clinical studies. To explore how Science 37 compares with its peers in the healthcare technology sector and access detailed financial analysis, visit InvestingPro for exclusive insights and industry benchmarks.
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