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

Core Insights - Science 37 successfully completed its third FDA inspection, receiving a No Action Indicated (NAI) recommendation, affirming the quality and compliance of its Direct-to-Patient Site for clinical research [1][3]. FDA Inspection Results - The recent FDA inspection evaluated Science 37's role in a Phase 3 primary biliary cholangitis (PBC) study, where it enrolled 47% of the US study population [2]. - This marks the third consecutive successful FDA inspection for Science 37 in less than two years, with previous inspections also resulting in NAI categorizations and no Form 483s issued [3]. Company Operations and Model - Science 37's Direct-to-Patient Site enhances clinical trial accessibility by allowing participation from patients' homes, thus overcoming geographic limitations of traditional sites [4]. - The company provides a comprehensive range of site services, including investigator oversight, research-grade nursing, CRC support, and direct-to-patient logistics, which facilitate faster enrollment and high-quality data delivery [4]. Partnerships and Goals - Science 37 continues to partner with clinical research sponsors to enhance trial accessibility and enrollment, aiming to accelerate clinical research and improve health outcomes [5][6].