Science 37, a clinical research organization specializing in direct-to-patient trials, has successfully completed its third consecutive FDA inspection with a No Action Indicated (NAI) categorization, reinforcing the regulatory compliance of its innovative clinical trial platform. The inspection concluded with no objectionable conditions noted and no Form 483 issued, marking a significant validation of the company's direct-to-patient research model.
FDA Inspection Focuses on Phase 3 PBC Study
The recent FDA review centered on Science 37's substantial contribution to a registrational Phase 3 primary biliary cholangitis (PBC) study, where the company enrolled 47% of the US study population. The inspection comprehensively evaluated the company's internal processes, technology platforms, data integrity, patient safety measures, protocol adherence, Principal Investigator oversight, and all associated documentation.
This marks Science 37's third consecutive successful FDA inspection in less than two years, with previous inspections conducted in March 2024 and April 2025 also resulting in NAI categorizations and no Form 483s issued. The consistent track record demonstrates the company's ability to deliver high-quality, regulatory-compliant research across multiple pivotal studies.
Direct-to-Patient Model Validation
"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. "Each FDA inspection underscores the strength of our Direct-to-Patient Site in upholding the highest regulatory standards and validates how we are advancing clinical research with a strong emphasis on quality and compliance."
Science 37's Direct-to-Patient Site extends clinical trial reach beyond the geographic limitations of traditional sites by enabling participation directly from patients' homes. The platform leverages nationwide recruitment capabilities and 50-state medical licensure to provide comprehensive site services, including investigator oversight, research-grade nursing, clinical research coordinator support, and direct-to-patient logistics.
Operational Impact and Future Implications
The company's platform facilitates faster enrollment and enhances trial accessibility while consistently delivering high-quality data across studies of varying complexity. The successful inspection outcomes validate the company's approach to expanding patient access to clinical trials while maintaining regulatory compliance standards.
Science 37 continues to partner with clinical research sponsors seeking to enhance trial accessibility and enrollment, positioning itself as a validated solution for direct-to-patient clinical research operations. The consecutive NAI ratings provide regulatory validation for sponsors considering alternative approaches to traditional site-based clinical trials.
