Science 37 and Tufts CSDD Publish Landmark Study on Direct-to-Patient Clinical Trial Site Performance, Outperforming Industry Benchmarks

MORRISVILLE, NC — May 19, 2026 — Science 37 today announced the publication of a new analysis in Applied Clinical Trials in collaboration with the Tufts Center for the Study of Drug Development (Tufts CSDD). The study evaluates the performance of Science 37’s Direct-to-Patient (DTP) Site against established industry benchmarks, providing an empirical assessment of how the DTP site model, when added along with traditional sites, can improve study performance.    

The Science 37 DTP model operates under centralized medical oversight, characterized by multi-state-licensed physicians, research-grade nurses conducting in-home visits, and specialized DTP clinical supply chains. The model has successfully undergone multiple FDA inspections, resulting in a repeated No Action Indicated (NAI) classification with no Form 483 observations or significant findings, and data generated through this approach has supported various regulatory submissions and approvals.

Quantifying the DTP Impact: Core Performance Metrics

The study analyzed 28 trials conducted via Science 37’s DTP Site against traditional Phase II and Phase III benchmarks. While the full publication details a comprehensive suite of efficiency and quality metrics, the following high-level outcomes demonstrate several operational and representational advantages of the DTP model:

"The data confirms that the DTP site model has the ability to change the paradigm for study performance in clinical research," said Tyler Van Horn, CEO of Science 37. "By reaching participants an average of nearly 60 miles from major airports, we are eliminating participation barriers and allowing sponsors to enroll diverse populations faster and more reliably when combined with traditional infrastructure."

The analysis includes studies in which Science’s 37’s DTP Site operated alongside traditional sites, demonstrating how hybrid approaches can enhance overall study performance while maintaining rigorous physician oversight and research-grade execution.

“The results of this important study add to our growing knowledge of virtual and remote solutions and their impact on study timelines and enrollment performance,” said Kenneth Getz, Executive Director and Professor, Tufts CSDD. “Empirical evidence consistently shows that a wide variety of DCT solutions, customized to the target patient population, improve speed and efficiency while offering higher levels of convenience and access to study participants.”

Access the Full Study

The data highlighted above represents only a portion of the comprehensive analysis conducted by Science 37 and Tufts CSDD. To review the complete methodology, expanded datasets, and in-depth conclusions, view the full study results here.

About Tufts CSDD

The Tufts Center for the Study of Drug Development (Tufts CSDD) is an internationally recognized nonprofit academic research center within the Tufts University School of Medicine focused on improving drug and biologics development. For over 50 years, Tufts CSDD has provided evidence-based research and analysis on the time, cost, risk, efficiency, and regulation of drug development.

As the only multidisciplinary academic center dedicated exclusively to optimizing drug development performance and economics, Tufts CSDD brings together expertise across medicine, public health, economics, business, law, pharmacology, and data science. Our mission is to deliver strategic, data-driven insights that help industry leaders, regulators, and policymakers make informed decisions across the global healthcare ecosystem.

In addition to publishing widely cited research, Tufts CSDD produces executive-level reports and newsletters, convenes industry stakeholders through forums and workshops, and offers professional development programs, including its longstanding Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation. Through research, collaboration, and education, Tufts CSDD remains committed to advancing a more efficient and evidence-driven future for drug development.

About Science 37

Science 37 is a modern clinical research site that delivers trials directly to patients’ homes. With nationwide reach and medical licensure across all 50 states, its Direct-to-Patient Site enables sponsors to expand access, improve retention, and enroll more representative patient populations compared to relying solely on a traditional site-based approach.

Science 37 operates under a single Form FDA 1572 and a central IRB, supported by centralized medical oversight, research-grade nursing, and specialized direct-to-patient clinical operations. The company has successfully completed multiple FDA inspections resulting in FDA approvals, achieving No Action Indicated (NAI) classifications with zero Form 483 observations.

With more than a decade of experience, Science 37 has supported over 200 clinical trials across Phases I–IV and observational studies. Its model consistently delivers strong performance, including approximately 86% completion rates and contributing an average of 20–30% of total study enrollment as a single site. These outcomes have been validated by the Tufts Center for the Study of Drug Development (Tufts CSDD).

To learn more, visit www.science37.com or email science37@science37.com.

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Disclaimer: This communication contains summaries of research findings and is provided for informational purposes only. Results described are based on specific studies and may not be indicative of future performance. Statements regarding potential benefits of the Direct-to-Patient model are subject to variability based on study design, therapeutic area, and other factors.

Science 37 Launches Dedicated Pediatrics Department to Expand Access to Specialized Clinical Research for Children and Families

MORRISVILLE, NC — March 17, 2026 — Science 37, the leader in expanding patient access to clinical trials, today announced the formal launch of its dedicated Pediatrics Department, reinforcing the company’s commitment to advancing pediatric research by reducing the logistical and emotional burden placed on families.

Pediatric clinical trials have historically struggled with slow enrollment, high dropout rates, and limited geographical reach due to the challenges families face traveling to traditional research sites. Science 37’s pediatric model brings specialized clinical trial activities directly into the home or school, enabling children to participate in research without disrupting school, family routines, or caregiver responsibilities.

Specialized Pediatric Expertise Built for Modern Clinical Research

The Pediatrics Department centralizes Science 37’s pediatric clinical and operational expertise under a dedicated leadership and delivery model designed specifically for children and adolescents. Central to the department’s success is a specialized in-house team trained in age-appropriate, family-centered clinical care, featuring:

Proven Results Across Pediatric Therapeutic Areas

Science 37 has supported more than 20 pediatric clinical trials across therapeutic areas, including asthma, Prader-Willi Syndrome, and restless leg syndrome. In a recent Phase 3 Fragile X Syndrome study, Science 37 was the top-enrolling site, contributing 25% of all patients and maintaining a 94% retention rate.

"As an industry, we have asked families to fit research into their lives, rather than designing research to fit into childhood," said Dr. Debra Weinstein, Chief Medical Officer at Science 37. "Our focus is on removing the barriers that prevent children from accessing potentially life-changing research, while maintaining the highest standards of safety, clinical rigor, and pediatric expertise."

About Science 37

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research. To learn more, visit www.science37.com or email science37@science37.com

To view studies that Science 37 is actively recruiting for, please visit https://studies.science37.com/current-studies

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Science 37 Appoints Kelly Johnston McKee as VP of Strategy & Transformation

MORRISVILLE, NC — January 27, 2026 — Science 37, the leader in expanding patient access to clinical trials, today announced the appointment of Kelly Johnston McKee as Vice President, Strategy & Transformation

In this role, McKee will lead the design of Science 37’s future-state patient experience, driving growth through modernized trial execution, advancing innovation, and strengthening cross-organizational collaboration to support long-term growth.

McKee brings more than 20 years of leadership experience in clinical innovation, patient engagement, and trial optimization. She is widely recognized for building high-impact ecosystems that accelerate enrollment, reduce costs, and elevate the participant experience. 

Her career includes senior leadership roles at AstraZeneca/Evinova, Medidata, Vertex, Eli Lilly, Merck, and Sanofi, where she specialized in translating innovative concepts into scalable, enterprise-ready solutions across clinical development and operations.

"Kelly’s expertise sits at the intersection of strategy, innovation, and execution, the exact space where Science 37 is focused," said Tyler Van Horn, CEO of Science 37. "Her ability to translate bold ideas into scalable impact will be instrumental as we advance next-generation patient experiences and deepen our industry partnerships."

As VP of Strategy & Transformation, McKee will focus on:

"Science 37 has long challenged conventional thinking around access and execution in clinical trials,” said McKee. “As the industry moves beyond experimentation, the opportunity now is to scale innovation and optimize experiences in a way that is operationally sound and holds meaningful value for patients, sites, and sponsors. I am excited to help shape that next phase.”  

About Science 37

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research. To learn more, visit www.science37.com or email science37@science37.com

To view studies that Science 37 is actively recruiting for, please visit https://studies.science37.com/current-studies

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Science 37 Named Finalist in Two Categories for the 2026 SCOPE Awards

MORRISVILLE, NC — January 7, 2026 — Science 37, the leader in expanding patient access to clinical trials, today announced it has been named a finalist for two prestigious SCOPE Awards: the Participant Engagement Award and the Site Innovation Award. This marks the first time that a single company has been named a finalist for two SCOPE Award categories in the same year.

Driving Engagement Through Community Pharmacies

Science 37 was recognized for the Participant Engagement Award for its “Pharm-to-Trial” partnership with RxE2. This decentralized vaccine trial model brings research to agricultural U.S. communities by utilizing local pharmacies as trusted access points. Supported by Science 37’s research-grade nurses and board-certified investigators, this "hub-and-spoke" model removes socioeconomic barriers and leverages local healthcare relationships to improve diversity and data quality.

Redefining the Clinical Trial Site

The nomination for the Site Innovation Award honors Science 37’s Direct-to-Patient Clinical Trial Site, which enables participation directly from patients’ homes. With nationwide reach supported by 50-state medical licensure, the site expands access beyond traditional site boundaries and accelerates enrollment for clinical trial sponsors.

“These nominations reflect our commitment to expanding patient access while delivering operational excellence,” said Tyler Van Horn, Chief Executive Officer of Science 37. “Being the first company recognized in two categories simultaneously is a testament to our team's dedication to making research more accessible and inclusive.”

Final judging will take place at the SCOPE Summit in Orlando, Florida, February 2–5, 2026.

About Science 37

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research. To learn more, visit www.science37.com or email science37@science37.com.

To view studies that Science 37 is actively recruiting for, please visit https://studies.science37.com/current-studies.

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Science 37 Honored for Site Innovation in the 2025 Clinical Trials Arena Excellence Awards

Science 37 Receives 2025 Clinical Trials Arena Site Innovation Award for R&D Leadership

MORRISVILLE, NC — December 2, 2025 — Science 37, the leader in expanding patient access to clinical trials, today announced that it has been awarded the Research and Development – Site Innovation honor in the 2025 Clinical Trials Arena Excellence Awards. The recognition highlights Science 37’s leadership in advancing clinical research through its Direct-to-Patient Clinical Trial Site, one of the industry’s most innovative and data-driven site models.

Powered by GlobalData’s independent research, the Clinical Trials Arena Excellence Awards celebrate organizations driving meaningful progress across key areas, including R&D, Safety, Diversity, and Social Impact.

Science 37’s Direct-to-Patient Site operates as a single, nationwide, FDA-inspected site that enables sponsors to enroll and retain participants in all 50 states. By eliminating geographic barriers, the model improves access, enhances equity, and consistently delivers high-quality performance across complex therapeutic areas.

Examples of recent contributions to sponsor programs, including:

“Receiving the Site Innovation Award reflects the transformative impact of our Direct-to-Patient Site,” said Tyler Van Horn, CEO of Science 37. “By enabling participation directly from the patient’s home, we’re broadening access, supporting regulatory confidence, and helping sponsors bring life-changing therapies to patients faster.”

As the first and only FDA-inspected Direct-to-Patient Clinical Trial Site, Science 37 has completed multiple inspections on pivotal Phase 3 trials, all resulting in No Action Indicated (NAI) outcomes. The model continues to deliver strong performance in complex programs, driving top enrollment in pivotal studies and supporting faster recruitment.

Read more about Science 37’s recognition.

About GlobalData

GlobalData Plc (AIM: DATA) is a leading data, insights, and analytics platform that delivers trusted proprietary insights and tailored intelligence solutions for the world's largest industries. The company’s mission is to help clients decode the future, make better decisions, and reach more customers.

By combining proprietary data with human expertise and powerful AI, GlobalData provides next-generation intelligence through one connected platform.

For more information, visit https://www.globaldata.com.

About Science 37

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research. To learn more, visit www.science37.com or email science37@science37.com.

To view studies that Science 37 is actively recruiting for, please visit https://studies.science37.com/current-studies.

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

MORRISVILLE, NC — October 8, 2025 — 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 a registrational Phase 3 primary biliary cholangitis (PBC) study, in which the company played a significant role, enrolling 47% of the US study population. The FDA evaluated internal processes, technology platforms, data integrity, patient safety measures, protocol adherence, Principal Investigator oversight, and all associated documentation.

This marks Science 37’s third consecutive successful FDA inspection in less than two years. Previous inspections in March 2024 and April 2025 also resulted in NAI categorizations, with no Form 483s issued, validating the company’s ability to consistently deliver high-quality, regulatory-compliant research across multiple pivotal studies.

“Our team’s consistent track record not only validates the rigor of our model but also demonstrates how direct-to-patient research can expand reach, safeguard patient safety, and deliver data of the highest integrity,” said Dr. Debra Weinstein, Chief Medical Officer at Science 37. “Each FDA inspection underscores the strength of our Direct-to-Patient Site in upholding the highest regulatory standards and validates how we are advancing clinical research with a strong emphasis on quality and compliance.”

Science 37’s Direct-to-Patient Site extends clinical trial reach beyond the geographic limitations of traditional sites by enabling participation directly from patients’ homes. Leveraging nationwide recruitment and 50-state medical licensure, Science 37 provides a comprehensive range of site services, including investigator oversight, research-grade nursing, CRC support, and direct-to-patient logistics. The site facilitates faster enrollment, enhances trial accessibility, and consistently delivers high-quality data across studies of varying complexity.

Science 37 continues to partner with clinical research sponsors seeking to enhance trial accessibility and enrollment. For more information, visit www.science37.com.

About Science 37

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research. To learn more, visit www.science37.com or email science37@science37.com.

To view studies that Science 37 is actively recruiting for, please visit https://studies.science37.com/current-studies.

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Science 37 and Catalent Announce Partnership Enabling Universal Access to Clinical Research

MORRISVILLE, NC — September 4, 2025 — Science 37, the leader in expanding patient access to clinical trials, and Catalent®, a global leader in enabling pharma, biotech, and consumer health partners to optimize product development and supply, announced a strategic partnership redefining how investigational medicinal products (IMPs) are delivered directly to patients’ homes for clinical research.

Through this collaboration, Catalent supports Science 37’s Direct-to-Patient Clinical Trial Site model by providing reliable, efficient shipping and logistics services for study medications, ensuring rapid and secure delivery of IMPs across geographies and enabling patients to participate in clinical research from the comfort of their homes, regardless of their location.

“Catalent’s expertise in direct-to-patient logistics is a key enabler of our mission to expand access to clinical trials,” said Tyler Van Horn, CEO at Science 37. “By removing geographic barriers, we’re not only reaching more diverse patient populations, we’re also driving faster enrollment and generating high-quality data that helps bring treatments to market sooner.”

Science 37 and Catalent have partnered to refine the IMP supply chain for at-home trial participation and visit execution. Across 17 studies, Catalent and Science 37's partnership enrolled nearly 1,700 patients by bringing clinical trials directly into the home, enrolling an average 26% of the total study population in a single Direct-to-Patient Site, with 9 patients enrolled per month or the equivalent of more than 15 brick-and-mortar locations in each instance. To date, the partnership has delivered over 6,400 shipments to study participants.

This integrated solution offers sponsors an end-to-end clinical trial site under a single contract and budget, streamlining operations, improving enrollment speed and retention rates, and expanding access to underserved and geographically dispersed populations.

“Our partnership with Science 37 transforms the clinical trial experience, bringing research directly to participants while preserving the rigor and efficiency on which sponsors rely,” said Ricky Hopson, President, Clinical and Specialty Services, and Chief of Staff at Catalent. “Together, we’re advancing a more inclusive and patient-centered future for clinical research, without compromising precision or quality.”

To learn more about how Science 37 and Catalent are transforming clinical research, visit www.science37.com and www.catalent.com.

About Catalent

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. 

For more information, visit www.catalent.com.

About Science 37

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research. To learn more, visit www.science37.com or email science37@science37.com.

To view studies that Science 37 is actively recruiting for, please visit https://studies.science37.com/current-studies.

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Science 37 Completes Second FDA Inspection as Enrollment Leader in Phase 3 Asthma Trial

MORRISVILLE, NC — April 8, 2025 — Science 37, a leader in enhancing patient access to clinical trials, today announced the successful completion of its second FDA inspection, reaffirming the quality of its Direct-to-Patient Site for clinical research. The inspection resulted in a No Action Indicated (NAI) categorization, with no objectionable conditions noted and no Form 483 issued.

Led by Science 37's internal Quality Assurance & Compliance team, the inspection focused on the company’s role in a registrational Phase 3 asthma study, which Science 37 contributed 28% of the total patient enrollment. The FDA evaluated internal processes, technology, data integrity, patient safety, protocol adherence, Principal Investigator oversight, and all associated documentation. This marks Science 37’s second successful FDA inspection within the last 13 months, following a similar review in March 2024 that assessed three pivotal Phase 3 trials.

“The results of this FDA inspection further validate the strength of our Direct-to-Patient Site in maintaining the highest regulatory standards while transforming clinical trial access,” said Irena Lambridis, VP and Head of Quality Assurance & Compliance at Science 37. “By expanding reach and ensuring rigorous oversight, we are helping sponsors accelerate timelines, optimize data integrity, and bring life-changing treatments to patients faster.”

“As an Investigator for Science 37, I have complete oversight of study visits through our telemedicine platform and close coordination with our research-grade nurses,” said Dr. Debra Weinstein, VP of Internal Medicine at Science 37. “Our Direct-to-Patient Site enables us to conduct comprehensive assessments and ensure protocol adherence remotely—delivering the quality and compliance validated by this FDA inspection.”

Science 37’s Direct-to-Patient Site empowers clinical trial sponsors to reach 100% of their target patient population by bringing research directly to patients’ homes. With nationwide reach, investigators with 50-state medical licensure, and research-grade nursing, the site enhances enrollment speed while delivering high-quality results.

Science 37 continues to partner with clinical research sponsors seeking to enhance trial accessibility and enrollment. For more information, visit www.science37.com.

About Science 37

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and improved health outcomes. Our solutions empower life sciences companies to reach diverse populations beyond traditional research methods. Learn more at www.science37.com or contact science37@science37.com.

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Science 37 Appoints Tyler Van Horn as CEO to Lead Next Era of Patient-Access Innovation

Seasoned Strategist and Former Chief Commercial Officer Poised to Accelerate Access and Equity in Clinical Research

MORRISVILLE, NC — January 14, 2025 — Science 37, a leader in enhancing patient access to clinical trials, announces the appointment of Tyler Van Horn as Chief Executive Officer. Formerly the company’s Chief Commercial Officer, Van Horn’s appointment follows his pivotal role in driving operational excellence and shaping the company’s strategic direction to better prioritize client success – initiatives credited with driving growth for the company.

Since joining Science 37 in 2021, Van Horn has been a chief architect in assembling and empowering a team capable of matching or surpassing the testing standards and data quality of traditional clinical trial sites. By emphasizing the well-being and safety of patients through the delivery of convenient, at-home services, Van Horn sees Science 37 solving the most acute patient enrollment and study conduct pain points facing its clinical research clients. 

“The future of clinical research lies in enabling therapies to reach their endpoints faster, gaining approval, and ensuring equitable, improved health outcomes for all,” said Van Horn. “As CEO, I am dedicated to supporting sponsors with our world-class research teams and innovative solutions. Our commitment to expanding patient access remains at the heart of everything we do, especially as we strive to reach underserved populations and drive meaningful change in healthcare.”

Van Horn’s elevation to CEO positions Science 37 to seamlessly build upon the learning of past successes. It also redoubles the company’s commitment to growth through purposeful innovation and enhanced solution delivery. By prioritizing the patient and study sponsors, Science 37 is leading the way, ushering in a new era of accessibility, diversity, and patient safety in clinical research. 

For more information about Science 37 and its unique approach to clinical research, visit www.science37.com.

About Science 37

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes. Our Direct-to-Patient Site and Patient Recruitment solutions enable life sciences companies to reach beyond traditional means of conducting clinical research. To learn more, visit www.science37.com, or email science37@science37.com.

To view studies that Science 37 is actively recruiting for, please visit https://studies.science37.com/current-studies

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