Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial

Rhea-AI Summary

Science 37 (SNCE) completed its third FDA inspection with a No Action Indicated (NAI) recommendation on Oct 8, 2025, and no Form 483 issued. The inspection reviewed processes, platforms, data integrity, patient safety, protocol adherence, and PI oversight for a registrational Phase 3 primary biliary cholangitis study in which Science 37 enrolled 47% of the US study population.

This is the company's third consecutive NAI in under two years (prior NAI outcomes in March 2024 and April 2025), highlighting consistent regulatory compliance for its Direct-to-Patient Site, nationwide recruitment and 50-state medical licensure, and site services including investigator oversight and research-grade nursing.

Positive

• FDA inspection result: No Action Indicated (NAI)
• No Form 483 issued in the Oct 8, 2025 inspection
• Enrolled 47% of the US population in the Phase 3 PBC study
• Third consecutive NAI outcome within less than two years
• 50-state medical licensure supporting nationwide recruitment

Negative

• None.

Insights

Clinical-trials quality expert

Third consecutive FDA NAI for the Direct-to-Patient Site and 47% US enrolment in a registrational Phase 3 study signal a clear regulatory-quality validation.

Science 37 demonstrated regulatory compliance across core trial functions: internal processes, technology platforms, data integrity, patient safety, protocol adherence, and investigator oversight. The inspector recommended a No Action Indicated (NAI) outcome and issued no Form 483; this is the third NAI in under two years, including inspections in March 2024 and April 2025.

Key dependencies and risks remain limited to items explicitly reviewed: sustaining documentation quality and oversight as trial scope expands. The company’s reported 47% share of US enrollment in the registrational Phase 3 PBC study is a measurable operational contribution but does not alone imply trial outcome or regulatory approval.

Watch the ongoing registrational Phase 3 study milestones and any future FDA communications for changes to inspection categorization; the most immediate monitorable items are subsequent FDA inspection reports and completion of Phase 3 enrollment. Given the recent inspection cadence, near-term signals should appear within months as sponsors report study progress.

MORRISVILLE, N.C., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Science 37, a leader in enhancing patient access to clinical trials, today announced the successful completion of its third FDA inspection, 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 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 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. For more information, visit www.science37.com.

About Science 37

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research. 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

What did Science 37 announce on Oct 8, 2025 about FDA inspections for SNCE?

Science 37 announced completion of its third FDA inspection with a No Action Indicated (NAI) recommendation and no Form 483 issued.

How much of the US enrollment did Science 37 provide in the Phase 3 PBC trial (SNCE)?

Science 37 enrolled 47% of the US study population in the registrational Phase 3 PBC trial.

How many consecutive successful FDA inspections has Science 37 had and when were the prior outcomes?

Science 37 has had three consecutive NAI inspections, including outcomes in March 2024, April 2025, and Oct 8, 2025.

What aspects did the FDA evaluate during the Oct 8, 2025 inspection of Science 37 (SNCE)?

The FDA evaluated internal processes, technology platforms, data integrity, patient safety measures, protocol adherence, PI oversight, and documentation.

What capabilities of Science 37’s Direct-to-Patient Site were highlighted by the inspection outcome?

The outcome underscored nationwide recruitment, 50-state licensure, investigator oversight, research-grade nursing, CRC support, and direct-to-patient logistics.

Does the Oct 8, 2025 inspection outcome indicate any FDA-observed deficiencies for Science 37 (SNCE)?

No; the inspection resulted in an NAI recommendation and the inspector noted no objectionable conditions and issued no Form 483.