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Science 37, a leader in enhancing patient access to clinical trials, announced the successful completion of its third US FDA inspection and further affirming the quality and compliance of its direct-to-patient site for clinical research. The inspection concluded with a no action indicated (NAI) categorization recommendation by the inspector, with no objectionable conditions noted and no Form 483 issued.
The review centered on Science 37’s contribution in a registrational phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role, enrolling 47% of the US study population. The US FDA evaluated 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 US FDA inspection in less than two years. Previous inspections in March 2024 and April 2025 also resulted in NAI categorizations, with no Form 483s issued, validating the company’s ability to consistently deliver high-quality, regulatory-compliant research across multiple pivotal studies.
“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. Leveraging nationwide recruitment and 50-state medical licensure, Science 37 provides a comprehensive range of site services, including investigator oversight, research-grade nursing, CRC support, and direct-to-patient logistics. The site facilitates faster enrollment, enhances trial accessibility, and consistently delivers high-quality data across studies of varying complexity.
Science 37 continues to partner with clinical research sponsors seeking to enhance trial accessibility and enrollment.
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