Science 37 Completes Second FDA Inspection as Enrollment Leader in Phase 3 Asthma Trial

Rhea-AI Summary

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.

Positive

• 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

Negative

• None.

Insights

Clinical Research Expert

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 30-50% of study delays.

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.

Financial Analyst

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 $34.7 million market capitalization. The regulatory validation of their Direct-to-Patient approach carries particular significance for a company of this size.

Their ability to contribute 28% of total enrollment in a Phase 3 registrational trial demonstrates meaningful scale and operational capability. For context, Phase 3 studies typically require hundreds of patients across multiple sites, making this a substantial enrollment contribution that validates their decentralized model.

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 100% of potential patient populations rather than just those near research centers, Science 37 offers sponsors a pathway to potentially reduce the timeline and cost of their most expensive development phase - late-stage clinical trials.

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 28% of the total patient enrollment. The FDA evaluated internal processes, technology, data integrity, patient safety, protocol adherence, Principal Investigator oversight, and all associated documentation. This marks Science 37’s second successful FDA inspection within the last 13 months, following a similar review in March 2024 that assessed three pivotal Phase 3 trials.

“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 100% of their target patient population by bringing research directly to patients’ homes. With nationwide reach, investigators with 50-state medical licensure, and research-grade nursing, the site enhances enrollment speed while delivering high-quality results.

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

Science 37 | PR@science37.com

FAQ

What was the outcome of Science 37's (SNCE) latest FDA inspection in April 2025?

Science 37 received a No Action Indicated (NAI) status with no Form 483 issued, indicating no objectionable conditions were found during the inspection.

How much did Science 37 (SNCE) contribute to the Phase 3 asthma trial enrollment?

Science 37 contributed 28% of the total patient enrollment in the registrational Phase 3 asthma study.

How many FDA inspections has Science 37 (SNCE) completed in the past 13 months?

Science 37 has completed two FDA inspections in the past 13 months, with the first in March 2024 and the second in April 2025.

What areas did the FDA evaluate during Science 37's (SNCE) latest inspection?

The FDA evaluated internal processes, technology, data integrity, patient safety, protocol adherence, Principal Investigator oversight, and associated documentation.