Science 37, the industry-leading patient access company, has won the Research and Development award in the Site Innovation category in the 2025 Clinical Trials Arena Excellence Awards for its transformative approach to clinical trial conduct.

By reimagining the clinical trial “site” as a single, nationwide, FDA-inspected operation, Science 37 has changed how sponsors access, enroll, and retain participants—especially those historically underserved by traditional brick-and-mortar models. The company’s Direct-to-Patient Site has demonstrated the ability to accelerate research timelines, improve participant diversity, and maintain high standards of data integrity and regulatory compliance.

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Nationwide reach and accelerated enrollment: Overcoming geographic limitations

Science 37’s approach fundamentally redefines the boundaries of clinical trial participation. Traditional sites are often limited to a 30-mile radius, restricting access for patients who live in rural or underserved regions. Through 50-state medical licensure and national patient identification, recruitment, and enrollment, Science 37 can reach patients across the entire United States. This model has proven effective, particularly in studies targeting rare diseases, pediatric populations, and conditions with strict eligibility criteria—areas where conventional recruitment methods frequently fall short.

The impact of this expanded reach is evident in several high-profile studies. In a pivotal Phase 3 asthma trial, Science 37 enrolled 28% of the total study population, making it the top enrolling site. The second-highest enroller, a leading research site network with 14 locations, collectively enrolled fewer participants than Science 37 alone. Notably, the study was FDA-inspected earlier this year. In a Phase 3 trial for Vascular Ehlers-Danlos Syndrome (vEDS), Science 37 enrolled 100% of study participants, overcoming the challenge of a geographically dispersed and medically fragile population. Similarly, in a Phase 4 narcolepsy study, Science 37 contributed 55% of total enrollment and enabled the sponsor to close recruitment five months ahead of schedule.

Science 37’s ability to rapidly identify, pre-screen, and enroll patients is not limited to large-scale studies. In a pivotal Phase 3 primary biliary cholangitis (PBC) study with GSK, Science 37 enrolled 47% of all U.S. participants. The trial was also recently FDA-inspected, marking Science 37’s third consecutive successful inspection within 18 months. Across multiple studies, Science 37 has consistently been the top enrolling site, with enrollment velocities up to 30 times higher than brick-and-mortar sites. This capacity to reach and engage patients regardless of location has allowed sponsors to achieve earlier interim analyses and advance study timelines, addressing one of the most persistent bottlenecks in clinical research.

In-home trial delivery and rigorous oversight: Supporting compliance and data quality

Science 37’s innovation extends beyond recruitment. By bringing procedures typically conducted at clinical sites directly into patients’ homes, the company has addressed longstanding barriers to participation and compliance. As part of this approach, Science 37 manages the full logistics of direct-to-patient trial delivery, encompassing temperature-controlled shipment of investigational medicinal products (IMPs), in-home intravenous administration, and the deployment of its in-house research-grade mobile nurses for both routine and advanced assessments.

The practical implications of this model are significant. For example, in a COVID-19 prophylaxis trial involving severely immunocompromised adults, Science 37 delivered blinded biologic therapies directly to patients’ homes, maintained temperature monitoring, and dispatched dual-nurse teams in full PPE for urgent in-home assessments. This approach enabled the enrollment of 42% of the immunocompromised cohort within just eight weeks, with a visit completion rate exceeding 90%. Similarly, in pediatric studies such as Fragile X Syndrome (FXS), Science 37 assigned only pediatric-trained nurses to conduct home visits, reducing stress for both patients and caregivers and achieving a 94% retention rate in a population known for high dropout risk.

Science 37’s operational rigor is further demonstrated by its regulatory track record. As the first and only FDA-inspected Direct-to-Patient Clinical Trial Site, Science 37 has successfully completed three FDA inspections across five phase 3 studies, resulting in a No Action Indicated (NAI) classification, with no findings or objections. The company’s in-house teams—including board-certified investigators, research-grade nurses, site operations specialists, and clinical research coordinators—ensure consistent oversight and quality across all studies. Science 37’s streamlined eligibility confirmation, and robust data capture protocols support audit-ready operations and high-quality data. In studies requiring complex assessments, such as those involving frequent specimen collection or IV administration, Science 37 has consistently maintained protocol adherence and data integrity while minimizing patient burden.

Driving diversity, retention, and sponsor collaboration: Advancing site performance standards

A key differentiator for Science 37 is its demonstrated impact on participant diversity, retention, and collaborative sponsor engagement. By removing logistical and geographic barriers, the company has enabled broader, more representative enrollment. In a colorectal cancer screening trial, for example, Science 37 achieved 24% minority representation, enrolling Black, Hispanic, and American Indian participants at rates that exceeded industry averages. In the COVID-19 prophylaxis study, 23% of enrolled patients were from minority backgrounds, reflecting the company’s ability to reach populations often underrepresented in clinical research.

Retention rates have also been notably high, even in challenging populations. In rare disease and pediatric studies, Science 37’s in-home model has led to retention rates above 90%, with participants and caregivers reporting greater comfort and willingness to remain engaged. For instance, in the narcolepsy trial, Science 37 achieved a 98% visit completion rate, and in the Fragile X Syndrome study, only three of 49 participants withdrew, none due to study drug or site performance.

Science 37’s collaborative approach with sponsors further sets it apart. The company actively diagnoses recruitment bottlenecks, refines prescreening tools, and shares operational best practices to improve overall study performance. In the narcolepsy study, Science 37’s insights led to a protocol amendment that reduced screen failure rates, and the company provided best practices to brick-and-mortar sites to enhance their performance. In an atrial fibrillation trial, Science 37 worked closely with the sponsor to redesign the prescreening process, fast-track medical record reviews, and streamline consent, resulting in a dramatic turnaround in enrollment pace.

By acting as a collaborative partner rather than a traditional service provider, Science 37 has contributed to improved study performance and operational efficiency. Its ability to diagnose and address recruitment challenges, support protocol compliance, and foster participant engagement has established a new standard for site innovation in the industry.

“Receiving the Site Innovation Award is a reflection of the transformative impact of Science 37’s Direct-to-Patient Site. By enabling clinical trial participation directly from the patient’s home, we’re removing geographic barriers, broadening access, and helping sponsors accelerate research and development. This recognition underscores our commitment to advancing a more inclusive, patient-centered approach to how clinical trials are conducted, one that delivers high-quality data, ensures regulatory confidence, and ultimately brings life-changing therapies to patients faster.”

– Tyler Van Horn, CEO, Science 37

Company Profile

Science 37 is the industry-leading patient access company redefining clinical trial enrollment through innovative patient- and site-centric solutions.

Founded more than a decade ago by investigators with a vision to make research accessible to anyone, anywhere, anytime, regardless of their proximity to research sites, Science 37 enables patients to discover, qualify for, and participate in clinical trials directly from home.

As the first and only FDA-inspected Direct-to-Patient Clinical Trial Site, Science 37 has demonstrated consistent quality and regulatory excellence, achieving multiple No Action Indicated (NAI) outcomes with no objectionable conditions noted and no Form 483s issued.

Through its Direct-to-Patient Site, Science 37 removes barriers of geography, access, and logistics, empowering sponsors to reach more participants, collect high-quality data, and shorten study timelines. With nationwide reach and a fully employed team of experienced clinical research professionals, the company ensures compliance, consistency, and an exceptional participant experience.

To date, Science 37 has supported more than 185 trials and over 13,000 home visits across therapeutic areas, helping life sciences companies accelerate enrollment, improve retention, and bring therapies to patients faster.

Learn more at www.science37.com or email science37@science37.com.

Contact Details

Email: science37@science37.com

Phone: (984) 377-3737

Links:

Website: https://www.science37.com/