Science 37 Completes Third FDA Inspection, Validating Quality of its Direct-to-Patient Site in Pivotal Phase 3 Rare Disease Trial
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.
Science 37 (SNCE) ha completato la terza ispezione FDA con una raccomandazione No Action Indicated (NAI) il 8 ottobre 2025, e nessuna Form 483 emessa. L'ispezione ha esaminato processi, piattaforme, integrità dei dati, sicurezza dei pazienti, aderenza al protocollo e supervisione del PI per uno studio registrazionale di Fase 3 su colangite biliare primitiva, in cui Science 37 ha arruolato il 47% della popolazione nello studio negli USA.
Questa è la terza NAI consecutiva dell'azienda in meno di due anni (precedenti outcome NAI a marzo 2024 e aprile 2025), evidenziando una conformità normativa costante per il suo Direct-to-Patient Site, il reclutamento su scala nazionale e licenze mediche per 50 stati, e servizi sul sito che includono supervisione degli investigatori e infermieristica di livello di ricerca.
Science 37 (SNCE) completó su tercera inspección de la FDA con una recomendación de No Action Indicated (NAI) el 8 de octubre de 2025, y no se emitió ningún Formulario 483. La inspección revisó procesos, plataformas, integridad de datos, seguridad del paciente, adherencia al protocolo y supervisión del PI para un estudio registracional de Fase 3 primaria de colangitis biliar primaria en el que Science 37 inscribió el 47% de la población del estudio en EE. UU..
Esta es la tercera NAI consecutiva de la empresa en menos de dos años (resultados NAI previos en marzo de 2024 y abril de 2025), destacando el cumplimiento normativo constante para su Direct-to-Patient Site, el reclutamiento a nivel nacional y licencia médica en 50 estados, y servicios del sitio que incluyen supervisión de investigadores y enfermería de nivel de investigación.
Science 37 (SNCE)가 2025년 10월 8일 No Action Indicated (NAI) 권고와 함께 세 번째 FDA 점검을 완료했으며, Form 483은 발급되지 않았습니다. 점검은 프로세스, 플랫폼, 데이터 무결성, 환자 안전, 프로토콜 준수, PI 감독을 검토했으며, Science 37이 미국 내 연구대상 인구의 47%를 등록한 주요 간질염 연구의 registrational Phase 3를 대상으로 했습니다.
이번 결과는 회사의 Direct-to-Patient Site에 대한 일관된 규제 준수, 전국적 모집, 50개 주 의 의료 면허를 포함한 사이트 서비스(연구책임자 감독 및 연구 등급 간호 포함)도 강조합니다.
Science 37 (SNCE) a terminé sa troisième inspection de la FDA avec une recommandation No Action Indicated (NAI) le 8 octobre 2025, et aucun Form 483 n’a été émis. L’inspection a examiné les processus, les plateformes, l’intégrité des données, la sécurité des patients, l’adhérence au protocole et la supervision du PI pour une étude primaria registrational de la phase 3 sur la cholangite biliaire primitive, au cours de laquelle Science 37 a recruté 47% de la population de l’étude aux États‑Unis.
C’est la troisième NAI consécutive de l’entreprise en moins de deux ans (résultats NAI antérieurs en mars 2024 et avril 2025), mettant en évidence une conformité réglementaire constante pour son Direct-to-Patient Site, le recrutement à l’échelle nationale et la licence médicale dans les 50 États, et des services de site incluant la supervision des investigateurs et une infirmière de recherche.
Science 37 (SNCE) hat am 8. Oktober 2025 seine dritte FDA-Inspektion mit einer Empfehlung No Action Indicated (NAI) abgeschlossen und es wurde kein Form 483 erteilt. Die Inspektion prüfte Prozesse, Plattformen, Datenintegrität, Patientensicherheit, Protokolleinhaltung und PI-Aufsicht für eine registrationale Phase-3-Studie zur primären biliären Cholangitis, bei der Science 37 47% der Studienpopulation in den USA rekrutierte.
Dies ist die dritte aufeinanderfolgende NAI des Unternehmens in weniger als zwei Jahren (frühere NAI-Ergebnisse im März 2024 und im April 2025), was eine konsistente regulatorische Compliance für seinen Direct-to-Patient Site, landesweites Recruiting und 50 Staaten medizinische Zulassungen sowie Site-Services einschließlich Investigator-Aufsicht und forschungsfähige Pflege hervorhebt.
Science 37 (SNCE) أكملت فحص FDA الثالث لها بتوصية No Action Indicated (NAI) في 8 أكتوبر 2025، ولم يتم إصدار نموذج 483. راجعت عملية الفحص وأسس المنصات ونزاهة البيانات وسلامة المرضى والالتزام بالبروتوكول والإشراف على PI لدراسة افتتاحية من المرحلة الثالثة مصرحة لمرض الالتهاب الصفراوي الأولي، والتي شاركت فيها Science 37 47% من سكان دراسة الولايات المتحدة.
هذه هي NAI الثلاثة للشركة في أقل من عامين (النتائج السابقة لـ NAI في مارس 2024 وأبريل 2025)، مما يبرز الالتزام التنظيمي المستمر لباع Direct-to-Patient Site والتوظيف على مستوى البلاد و ترخيص طبي في جميع الولايات الخمسين، وخدمات الموقع بما في ذلك إشراف المحققين وتمريض عالي البحث.
Science 37 (SNCE) 于 2025 年 10 月 8 日完成了第三次 FDA 检查，获得 No Action Indicated (NAI) 的建议，未签发 Form 483。此次检查评审了流程、平台、数据完整性、患者安全、方案遵循以及 PI 监督，针对一项用于注册性 Phase 3 的原发性胆汁淤积性疾病研究，在该研究中 Science 37 招募了 美国研究人群的 47%。
这是公司在不到两年的时间内连续第三次获得 NAI（2024 年 3 月和 2025 年 4 月的先前 NAI 结果），突显其 Direct-to-Patient Site 的持续合规、全国招募能力以及 50 州的医疗执照，以及包括研究者监督和研究级护理在内的站点服务。
- 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
- None.
Insights
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
Key dependencies and risks remain limited to items explicitly reviewed: sustaining documentation quality and oversight as trial scope expands. The company’s reported
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
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
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FAQ
What did Science 37 announce on Oct 8, 2025 about FDA inspections for SNCE?
How much of the US enrollment did Science 37 provide in the Phase 3 PBC trial (SNCE)?
How many consecutive successful FDA inspections has Science 37 had and when were the prior outcomes?
What aspects did the FDA evaluate during the Oct 8, 2025 inspection of Science 37 (SNCE)?
What capabilities of Science 37’s Direct-to-Patient Site were highlighted by the inspection outcome?
Does the Oct 8, 2025 inspection outcome indicate any FDA-observed deficiencies for Science 37 (SNCE)?
