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Science 37 Completes Second FDA Inspection as Enrollment Leader in Phase 3 Asthma Trial
Globenewswireยท 2025-04-08 12:00
Core Insights - Science 37 successfully completed its second FDA inspection, receiving a No Action Indicated (NAI) categorization, which indicates no objectionable conditions were noted [1][2] - The inspection evaluated the company's role in a Phase 3 asthma study, where Science 37 contributed 28% of total patient enrollment [2] - This marks the second successful FDA inspection for Science 37 within 13 months, following a review in March 2024 that assessed three pivotal Phase 3 trials [2] Company Operations - The inspection focused on various aspects including internal processes, technology, data integrity, patient safety, protocol adherence, and Principal Investigator oversight [2] - Science 37's Direct-to-Patient Site allows clinical trial sponsors to reach 100% of their target patient population by conducting research directly in patients' homes [3] - The company enhances enrollment speed and ensures high-quality results through nationwide reach and research-grade nursing [3] Leadership Statements - The VP and Head of Quality Assurance & Compliance at Science 37 emphasized the importance of maintaining high regulatory standards while improving clinical trial access [3] - An Investigator at Science 37 highlighted the effectiveness of the telemedicine platform in overseeing study visits and ensuring protocol adherence remotely [3] Partnerships and Goals - Science 37 continues to collaborate with clinical research sponsors to improve trial accessibility and enrollment [4] - The company aims to accelerate clinical research, leading to faster approvals and improved health outcomes by reaching diverse populations [5]