Announcement • Jun 15
Science 37 Holdings, Inc. Surpasses Enrollment Goals, Accelerates Phase 2 Rare Disease Clinical Trial Science 37 Holdings, Inc. announced the final enrollment figures from its 20-month engagement with a clinical-stage drug development company advancing novel small molecule therapeutics for systemic neuro-immune disorders. Science 37 augmented the recruitment and enrollment activities taking place at study sites nationwide for this ongoing Phase 2 trial evaluating the effects of EP547 in patients with Cholestatic Pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis. The study protocol mandated a highly specific patient population, requiring participants to undergo evaluation against rigorous inclusion and exclusion criteria. Leveraging its proprietary Metasite™ and Patient Recruitment solutions, Science 37 contributed 21% of all randomized study participants between September 2022 and April 2024. Science 37 surpassed its contracted enrollment goal, achieving an average enrollment rate of 1 patient per month, compared to the 0.1 patients per month rate at each of the 51 participating traditional brick-and-mortar sites. Announcement • May 15
Science 37 Holdings, Inc. Metasite Undergoes Successful FDA Inspection, Marking Major Milestone in Virtual Site Quality Assurance and Compliance Science 37 Holdings, Inc. announced the preliminary outcome of its recent FDA Inspection focusing on critical areas and documentation. The nearly two-week review included, but was not limited to, the Science 37 Metasite model and internal processes, technology utilized to support each trial, data integrity, efficacy, subject safety, protocol deviations, collaboration across teams, and, most importantly, Principal Investigator oversight. Conducted between February 26 and March 6, 2024, the first-of-its-kind FDA inspection yielded success with no significant issues identified ("No Action Indicated") and no objectionable conditions or practices identified during the closing meeting. The inspection was hosted by Science 37's internal Quality Assurance & Compliance team, led by Irena Lambridis, VP, Head of Quality Assurance & Compliance at Science 37. In addition to these findings, the inspectors noted Science 37's knowledge and ability to articulate details outlining each project, and comprehensive responses to all questions with documentation as evidence when requested. The Science 37 Metasite is a Virtual Site that enables universal trial access for patients and expands the reach of clinical research beyond traditional sites. It allows patients to participate in clinical trials from the comfort of their own homes or at local community providers. The Metasite is powered by a proprietary technology platform and in-house medical and operational experts, which ensure uniform study orchestration, greater compliance, and high-quality data. It aims to accelerate clinical research and increase patient diversity in trials. Announcement • May 03
Science 37 Holdings, Inc. Delivers 22x Faster Enrollment Than Traditional Methods in Phase 3 Asthma Clinical Trial Science 37 Holdings, Inc. disclosed the latest enrollment figures resulting from its Metasite™ and Patient Recruitment partnership with a leading biotech company whose asthma drug is currently undergoing a Phase 3 clinical trial. Leveraging its proprietary Metasite™ and Patient Recruitment solutions, Science 37 contributed 28% of all randomized study participants over a 15-month enrollment window. Science 37 averaged 44 patients enrolled per month, while each of the 55 brick-and-mortar sites supporting the trial enrolled an average of two participants per month. Science 37 delivered an enrollment velocity 22x greater than study sites in the trial and reduced the study’s overall time-to-target enrollment. Science 37’s Patient Recruitment is available on a standalone basis to clinical research sponsors and CROs looking to enhance their patient enrollment efforts, or in combination with Science 37’s Virtual Site, the Metasite™, as part of an accelerated research offering. 
