Science 37 Completes Second FDA Inspection as Enrollment Leader in Phase 3 Asthma Trial
Science 37 has successfully completed its second FDA inspection of its Direct-to-Patient Site, receiving a No Action Indicated (NAI) status with no Form 483 issued. The inspection focused on the company's participation in a Phase 3 asthma study, where Science 37 contributed 28% of total patient enrollment.
The FDA evaluation covered internal processes, technology, data integrity, patient safety, protocol adherence, Principal Investigator oversight, and documentation. This follows a previous successful FDA inspection in March 2024 that reviewed three pivotal Phase 3 trials.
Science 37's Direct-to-Patient Site enables clinical trial sponsors to reach 100% of target patient populations through home-based research, supported by investigators with 50-state medical licensure and research-grade nursing services.
Science 37 ha completato con successo la sua seconda ispezione da parte della FDA del suo Sito Direttamente al Paziente, ricevendo uno stato di Nessuna Azione Indicata (NAI) senza alcun modulo 483 emesso. L'ispezione si è concentrata sulla partecipazione dell'azienda a uno studio sull'asma di Fase 3, in cui Science 37 ha contribuito al 28% dell'arruolamento totale dei pazienti.
La valutazione della FDA ha coperto processi interni, tecnologia, integrità dei dati, sicurezza dei pazienti, rispetto del protocollo, supervisione del Ricercatore Principale e documentazione. Questo segue un precedente ispezione da parte della FDA avvenuta a marzo 2024 che ha esaminato tre trial pivotal di Fase 3.
Il Sito Direttamente al Paziente di Science 37 consente agli sponsor di studi clinici di raggiungere il 100% delle popolazioni target di pazienti attraverso la ricerca domiciliare, supportata da investigatori con licenze mediche valide in tutti i 50 stati e servizi infermieristici di alta qualità.
Science 37 ha completado con éxito su segunda inspección de la FDA en su Sitio Directo al Paciente, recibiendo un estatus de No Se Indica Acción (NAI) sin que se emitiera el formulario 483. La inspección se centró en la participación de la empresa en un estudio de asma de Fase 3, donde Science 37 contribuyó con el 28% del total de la inscripción de pacientes.
La evaluación de la FDA cubrió los procesos internos, la tecnología, la integridad de los datos, la seguridad del paciente, el cumplimiento del protocolo, la supervisión del Investigador Principal y la documentación. Esto sigue a una exitosa inspección de la FDA en marzo de 2024 que revisó tres ensayos clínicos fundamentales de Fase 3.
El Sitio Directo al Paciente de Science 37 permite a los patrocinadores de ensayos clínicos alcanzar el 100% de las poblaciones objetivo de pacientes a través de la investigación en el hogar, respaldada por investigadores con licencias médicas en los 50 estados y servicios de enfermería de calidad investigativa.
Science 37는 자사 환자 직접 사이트에 대한 두 번째 FDA 검사를 성공적으로 완료하였으며, 조치 없음 (NAI) 상태를 받았고 483 양식이 발행되지 않았습니다. 이번 검사는 회사의 3상 천식 연구 참여에 초점을 맞추었으며, Science 37은 전체 환자 등록의 28%를 기여했습니다.
FDA 평가는 내부 프로세스, 기술, 데이터 무결성, 환자 안전, 프로토콜 준수, 주요 연구자 감독 및 문서화 등을 포함했습니다. 이는 2024년 3월에 진행된 세 가지 주요 3상 시험을 검토한 이전의 성공적인 FDA 검사에 이어지는 것입니다.
Science 37의 환자 직접 사이트는 임상 시험 스폰서가 50개 주의 의사 면허와 연구 등급 간호 서비스로 지원되는 가정 기반 연구를 통해 목표 환자 집단의 100%에 도달할 수 있도록 합니다.
Science 37 a réussi à compléter sa deuxième inspection par la FDA de son Site Direct au Patient, recevant un statut de Aucune Action Indiquée (NAI) sans qu'aucun formulaire 483 ne soit émis. L'inspection s'est concentrée sur la participation de l'entreprise à une étude sur l'asthme de Phase 3, où Science 37 a contribué à 28 % de l'inscription totale des patients.
L'évaluation de la FDA a couvert les processus internes, la technologie, l'intégrité des données, la sécurité des patients, le respect du protocole, la supervision de l'Investigateur Principal et la documentation. Cela fait suite à une précédente inspection réussie de la FDA en mars 2024 qui a examiné trois essais cliniques pivots de Phase 3.
Le Site Direct au Patient de Science 37 permet aux sponsors d'essais cliniques d'atteindre 100 % des populations cibles de patients grâce à une recherche à domicile, soutenue par des chercheurs ayant une licence médicale dans les 50 États et des services infirmiers de qualité recherche.
Science 37 hat erfolgreich seine zweite FDA-Inspektion seiner Direkt-zu-Patienten-Website abgeschlossen und den Status Keine Maßnahmen angezeigt (NAI) erhalten, ohne dass ein Formular 483 ausgestellt wurde. Die Inspektion konzentrierte sich auf die Teilnahme des Unternehmens an einer Phase-3-Asthma-Studie, an der Science 37 28% der Gesamteinschreibung der Patienten beitrug.
Die Bewertung durch die FDA umfasste interne Prozesse, Technologie, Datenintegrität, Patientensicherheit, Einhaltung des Protokolls, Aufsicht des Hauptforschers und Dokumentation. Dies folgt auf eine frühere erfolgreiche FDA-Inspektion im März 2024, die drei entscheidende Phase-3-Studien überprüfte.
Die Direkt-zu-Patienten-Website von Science 37 ermöglicht es Sponsoren klinischer Studien, 100% der Zielpatientenpopulationen durch forschungsbasierte Heimstudien zu erreichen, unterstützt von Forschern mit medizinischer Lizenz in allen 50 Bundesstaaten und pflegerischen Dienstleistungen auf Forschungsniveau.
- Successful FDA inspection with No Action Indicated (NAI) status
- Strong enrollment performance with 28% contribution in Phase 3 asthma trial
- Second consecutive successful FDA inspection within 13 months
- Nationwide reach with 50-state medical licensure capability
- None.
Insights
Science 37's achievement of a No Action Indicated (NAI) FDA inspection result represents a significant regulatory validation for their decentralized clinical trial approach. In the regulated world of clinical research, an NAI classification without any Form 483 observations is the best possible outcome, indicating full compliance with FDA regulations and Good Clinical Practice standards.
Their 28% enrollment contribution to a registrational Phase 3 asthma study demonstrates that their Direct-to-Patient model can deliver substantial patient recruitment capabilities for pivotal trials. This is particularly noteworthy as patient recruitment consistently ranks among the top challenges in clinical research, often accounting for
This second successful FDA inspection within 13 months establishes a pattern of regulatory compliance that significantly de-risks their innovative trial methodology. For sponsors of complex late-stage trials, this validation eliminates a major concern about using novel approaches - regulatory acceptability of the data generated.
Science 37's model of nationwide investigators with 50-state licensure paired with research-grade nursing creates a scalable infrastructure that can potentially accelerate enrollment timelines across therapeutic areas. This successful inspection essentially confirms that their decentralized approach meets the same rigorous standards as traditional site-based research while potentially offering broader geographic reach.
The successful FDA inspection reinforces Science 37's value proposition in the clinical trial ecosystem and represents a meaningful milestone for the company given its
Their ability to contribute
From a business development perspective, this second clean FDA inspection strengthens Science 37's position when negotiating with pharmaceutical sponsors. Clinical trial sponsors are naturally conservative about adopting new methodologies without regulatory precedent, making this validation particularly valuable for future contract acquisition.
The Direct-to-Patient model addresses a fundamental economic challenge in clinical trials - the high cost and time expenditure of traditional site-based patient recruitment. By enhancing access to
MORRISVILLE, N.C., April 08, 2025 (GLOBE NEWSWIRE) -- Science 37, a leader in enhancing patient access to clinical trials, today announced the successful completion of its second FDA inspection, reaffirming the quality of its Direct-to-Patient Site for clinical research. The inspection resulted in a No Action Indicated (NAI) categorization, with no objectionable conditions noted and no Form 483 issued.
Led by Science 37's internal Quality Assurance & Compliance team, the inspection focused on the company’s role in a registrational Phase 3 asthma study, which Science 37 contributed
“The results of this FDA inspection further validate the strength of our Direct-to-Patient Site in maintaining the highest regulatory standards while transforming clinical trial access,” said Irena Lambridis, VP and Head of Quality Assurance & Compliance at Science 37. “By expanding reach and ensuring rigorous oversight, we are helping sponsors accelerate timelines, optimize data integrity, and bring life-changing treatments to patients faster.”
“As an Investigator for Science 37, I have complete oversight of study visits through our telemedicine platform and close coordination with our research-grade nurses,” said Dr. Debra Weinstein, VP of Internal Medicine at Science 37. “Our Direct-to-Patient Site enables us to conduct comprehensive assessments and ensure protocol adherence remotely—delivering the quality and compliance validated by this FDA inspection.”
Science 37’s Direct-to-Patient Site empowers clinical trial sponsors to reach
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 improved health outcomes. Our solutions empower life sciences companies to reach diverse populations beyond traditional research methods. Learn more at www.science37.com or contact science37@science37.com.
Media Inquiries
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FAQ
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