MORRISVILLE, N.C., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Science 37, a leader in enhancing patient access to clinical trials, today announced the successful completion of its third FDA inspection, further affirming the quality and compliance of its Direct-to-Patient Site for clinical research. The inspection concluded with a No Action Indicated (NAI) categorization recommendation by the inspector, with no objectionable conditions noted and no Form 483 issued. The review centered on Science 37’s contribution in ...

Core Insights - Science 37 and Catalent have formed a strategic partnership to enhance the delivery of investigational medicinal products (IMPs) directly to patients' homes for clinical research [1][2] - The collaboration aims to remove geographic barriers, allowing for more diverse patient populations and faster enrollment in clinical trials [3] Company Overview - Science 37 focuses on expanding patient access to clinical trials, leading to quicker approvals and improved health outcomes [8] - Catalent is a global leader in contract development and manufacturing, dedicated to supporting product development and supply for pharma, biotech, and consumer health sectors [6] Partnership Details - Catalent provides logistics services for Science 37's Direct-to-Patient Clinical Trial Site model, ensuring efficient and secure delivery of study medications [2] - The partnership has successfully enrolled nearly 1,700 patients across 17 studies, with an average of 26% of the total study population enrolled at a single Direct-to-Patient Site [3] Operational Benefits - The integrated solution offers sponsors a streamlined clinical trial site under a single contract and budget, improving enrollment speed and retention rates [4] - The partnership has delivered over 6,400 shipments to study participants, demonstrating its operational efficiency [3]

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]

Company Overview - Science 37 has appointed Tyler Van Horn as Chief Executive Officer, previously serving as Chief Commercial Officer, credited with driving operational excellence and strategic direction [1][2] - The company focuses on enhancing patient access to clinical trials, aiming to solve patient enrollment and study conduct challenges for clinical research clients [2][3] Leadership Vision - Van Horn emphasizes the importance of enabling therapies to reach endpoints faster, gaining approvals, and ensuring equitable health outcomes [3] - The commitment to expanding patient access is central to Science 37's mission, particularly in reaching underserved populations [3] Strategic Direction - Van Horn's leadership is expected to build upon past successes and enhance the company's growth through innovation and improved solution delivery [3] - Science 37 aims to lead in accessibility, diversity, and patient safety within the clinical research sector [3]

Core Insights - Science 37 has opened a new 19,000-square-foot corporate headquarters in Morrisville, North Carolina, enhancing its operational capabilities in the Research Triangle Park [1][2] - The new facility will centralize operations, allowing for improved collaboration among cross-functional teams, which will lead to better patient recruitment and study conduct support for clinical trial sponsors [2][3] - CEO David Coman emphasized that the relocation positions the company to better assist sponsors in overcoming challenges related to recruiting and treating hard-to-reach patient populations, reflecting a commitment to the region and improving sponsors' success rates [3] Company Overview - Science 37 aims to accelerate clinical research by providing universal trial access for patients through its Metasite™ and Patient Recruitment solutions, which extend the reach of clinical trials beyond traditional sites [4] - The company's proprietary technology stack, combined with in-house medical and operational expertise, enhances quality through standardized workflows and effective study orchestration [4]

Core Insights - Science 37 has successfully enhanced patient access to clinical trials through a partnership with a biopharmaceutical company focused on infectious disease prevention research, specifically in recruiting an immunocompromised patient cohort for a Phase 3 trial [1][2]. Patient Recruitment and Enrollment - Utilizing its proprietary Virtual Site and Patient Recruitment solutions, Science 37 identified, recruited, medically qualified, and enrolled 129 patients across 36 states within an 8-week period, averaging 65 patients per month [2]. - As the top-enrolling site, Science 37 randomized and treated 42% of the patient cohort, achieving significant geographic, socio-economic, and cultural diversity among participants [2]. Challenges and Solutions - The complexity of certain studies makes recruitment and enrollment inherently challenging, particularly for rare conditions or sensitive patient populations, highlighting Science 37's capability to meet demanding clinical trial requirements while improving access for vulnerable groups in a decentralized manner [3]. - Science 37 offers its Patient Recruitment services on a standalone basis or in combination with its flagship Virtual Site, the Metasite™, to enhance patient enrollment efforts [3]. Company Overview - Science 37's mission is to accelerate clinical research by providing universal trial access for patients, utilizing solutions like the Metasite™ and Patient Recruitment to expand the reach of clinical trials beyond traditional sites [4]. - The company's proprietary technology stack, along with in-house medical and operational experts, enhances quality through standardized workflows and best-in-class study orchestration [4].

Core Insights - Science 37 has been integrated into over 20 studies that were experiencing recruitment delays, helping them to align with their projected enrollment targets [1][2] - The company utilizes its proprietary Virtual Site and Patient Recruitment solutions to efficiently identify, recruit, and enroll patients without geographic limitations [1][6] - Science 37's services are applicable across various therapeutic areas, including Hematology, Hepatology, Infectious Diseases, CNS, Oncology, and Rare Diseases [2][6] Company Overview - Science 37 aims to accelerate clinical research by providing universal trial access for patients through its Metasite™ and Patient Recruitment solutions [6] - The company employs a proprietary technology stack and in-house medical and operational experts to enhance the quality of clinical trials through standardized workflows [6] - Science 37's Patient Recruitment can be utilized independently or in conjunction with its flagship Metasite™ to improve patient enrollment efforts [5][6]

Core Insights - Science 37 has been added to over 20 studies that were lagging in recruitment, helping them to trend back towards their projected targets [1] - The company leverages its proprietary Virtual Site and Patient Recruitment solutions to efficiently identify, recruit, medically qualify, and enroll patients without geographic restrictions [1][6] - Science 37's mission is to accelerate clinical research by enabling universal trial access for patients [6] Company Solutions - Science 37 provides Patient Recruitment as a standalone service or in combination with its flagship Virtual Site, the Metasite™, to enhance patient enrollment efforts [5] - The company has successfully supplemented enrollment in various studies, including Phase 2 through Phase 4 and Observational trials across multiple therapeutic areas such as Hematology, Hepatology, Infectious Diseases, CNS, Oncology, and Rare Diseases [2] - The solutions are powered by a proprietary technology stack with in-house medical and operational experts, enhancing quality through standardized workflows and best-in-class study orchestration [6]

Core Insights - Science 37 Holdings, Inc. is enhancing patient access to clinical trials, achieving significant enrollment figures in collaboration with a clinical-stage drug development company focused on systemic neuro-immune disorders [2][5] - The company utilizes its proprietary Metasite™ and Patient Recruitment solutions to broaden the recruitment pool beyond traditional geographic limitations, which is crucial for rare disease research [3][4] Enrollment Achievements - Science 37 contributed to 21% of all randomized study participants from September 2022 to April 2024, surpassing its contracted enrollment goal [8] - The average enrollment rate achieved by Science 37 was 1 patient per month, compared to only 0.1 patients per month at each of the 51 traditional study sites [8] Technology and Solutions - The Metasite™ and Patient Recruitment solutions are designed to enhance clinical trial enrollment by rigorously qualifying patients and expanding access beyond traditional sites [4][6] - Science 37's approach is supported by a proprietary technology stack and in-house medical and operational experts, ensuring quality through standardized workflows [4]

Core Insights - Science 37 is enhancing patient recruitment and enrollment for clinical trials, particularly for a Phase 2 trial evaluating EP547 in patients with Cholestatic Pruritus due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis [1] - The company offers standalone patient recruitment services or in combination with its Metasite™ to improve enrollment efforts for clinical research sponsors and CROs [2] - Science 37's mission is to accelerate clinical research by providing universal trial access, utilizing proprietary technology and expert teams to enhance the quality of patient recruitment [6] Enrollment Performance - Science 37 contributed 21% of all randomized study participants from September 2022 to April 2024, surpassing its contracted enrollment goal [7] - The average enrollment rate achieved by Science 37 was 1 patient per month, significantly higher than the 0.1 patients per month rate at traditional sites [7] Recruitment Strategy - Traditional recruitment methods are limited by geography, while Science 37 can recruit patients from anywhere, which is crucial for rare disease research [5] - The company rigorously qualifies patients before referring them to traditional trial sites, expanding the reach of clinical trials [6]