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

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

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 Metasite™ 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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Science 37 Nearly Doubles U.S. Enrollment for GSK Phase 3 Rare Disease Trial

Science 37, a leader in enhancing patient access to clinical trials, was a key enrolling site for the primary completion of a Phase 3 rare disease trial sponsored by global biopharmaceutical company, GSK. The hepatology study of an investigational medicine for cholestatic pruritus in primary biliary cholangitis (PBC) required 230 global participants, of which Science 37 was able to contribute almost half (17 - 47%) of the U.S. enrollment for the study.

Recognizing that the available participant population for rare disease studies is often extremely limited and dispersed globally, GSK welcomed an innovative approach to expanding trial access—one that would also help patients overcome symptom-based barriers such as fatigue that make it challenging to adhere to frequent site visits required in traditional clinical trials. Science 37's Direct-to-Participant Site solution allowed participants to take part in the study from home, reducing participant burden, especially if they lived far from traditional brick-and-mortar sites. By extending geographic access and facilitating real-time, at-home data collection, Science 37 significantly expanded the pool of qualified participants, a key factor to its U.S. enrollment contribution.

“At GSK, we design trials with a patient centric approach which leverages technology and remote services in order to make trials more accessible for participation. Science 37’s innovative services meant we could bring the trial to the homes or neighborhoods of patients in rural areas who would typically have to travel hundreds of miles to the nearest clinical site, which may otherwise have been a barrier to participating,” said Brandon Maggio, Global Head of Digital Operations & Process Optimization at GSK.

GSK’s ongoing commitment to producing research data of the highest quality has led them to emphasize trial solutions that enhance the patient experience. Science 37 had the capabilities to screen across most U.S. states, in many places where there were no brick-and-mortar sites participating. Additionally, Science 37 enabled participants at risk of dropping out from traditional brick-and-mortar sites to transition seamlessly to an at-home trial experience, enhancing engagement while maintaining study continuity. This strategy led to impressive results, with 82.3% completing Part A of the trial—the crucial milestone for evaluating the investigational drug's initial effects compared to placebo.

"Once again, Science 37 has demonstrated its unique ability to meet the needs of study sponsors confronted by the most challenging enrollment and study conduct conditions,” said Dr. Debra Weinstein, VP of Internal Medicine and Principal Investigator at Science 37. “The enhanced access of a decentralized approach becomes invaluable when sponsors are dealing with small patient populations that are widely dispersed across countries or even continents.”

For more information about Science 37’s enrollment solutions and its role in delivering qualified participants to clinical research studies such as the GSK PBC trial, please visit www.science37.com.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

About Science 37

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes. Our Metasite™ 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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Science 37 Earns Frost & Sullivan’s 2024 Global Company of the Year Award for Decentralized Clinical Trials

Top Honor Recognizes Science 37’s Visionary Innovation, Market-Leading Performance, and Unmatched Customer Care in the Decentralized Clinical Trials Industry

MORRISVILLE, NC — September 16, 2024 — Today, Science 37, a leader in enhancing patient access to clinical trials, announced that it has received Frost & Sullivan’s 2024 Global Company of the Year Award. Recognizing the market participant that exemplifies visionary innovation, market-leading performance, and unmatched customer care, the award solidifies Science 37’s growing influence in the clinical trial industry as it increasingly turns to decentralization to help overcome recruitment, enrollment, and retention challenges.

The internationally respected business consulting firm selected Science 37 after applying a rigorous analytical process that considered multiple nominees. A detailed evaluation of Best Practices criteria across two dimensions resulted in Science 37 earning the consultancy’s top honor in the decentralized clinical trials space. “Frost & Sullivan applauds Science 37 for its exemplary implementation of best practices driven by an excellent development strategy,” commented Valentina Barcia, Best Practices Research Analyst at Frost & Sullivan.

"We are deeply honored to receive Frost & Sullivan’s Best Practices Award," said David Coman, Chief Executive Officer at Science 37. "This recognition as the leader in decentralized clinical trials underscores the vision, dedication, and hard work of our entire team. We remain committed to transforming the clinical trial process to better serve patients and sponsors alike."

To learn more about Science 37 and its award-winning approach, read the full Frost & Sullivan report.

About Frost & Sullivan

 For six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders, and governments navigate economic changes and identify disruptive technologies, Mega Trends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. For more information, visit www.frost.com.

About Science 37

Science 37’s mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; the Metasite™ and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by a proprietary technology stack with in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. 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

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Science 37 Unveils New Corporate Headquarters in Research Triangle Park, NC

19,000-square-foot facility reflects the company’s recent growth and continued commitment to the region

MORRISVILLE, NC — August 6, 2024 — Science 37, a leader in enhancing patient access to clinical trials, today announced the grand opening of its new, 19,000-square-foot corporate headquarters in Morrisville, North Carolina, in the heart of Research Triangle Park.

The new, state-of-the-art facility, will serve as a hub for all Science 37 operations, enabling cross-functional teams with greater opportunities for collaborative problem-solving and integrated solution delivery. Centralizing operations in one facility will enable Science 37 to deliver patient recruitment and study conduct support on behalf of clinical trial sponsors with greater consistency, speed, and quality.

When asked about relocating to their new offices, Science 37 Chief Executive Officer, David Coman, stated, “Practically speaking, we’re better situated than ever to help our sponsors navigate the challenges of recruiting, enrolling, and treating difficult-to-reach patient populations. Symbolically, this move is just as important. It demonstrates our commitment to the region and to helping our sponsors improve their probability of success.”


To learn more about the Science 37, please visit www.science37.com.

About Science 37

Science 37’s mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; the Metasite™ and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by a proprietary technology stack with in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. 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
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Science 37 Enrolls 42% of Trial Cohort in 8 Weeks

Science 37 Supports Phase 3 Clinical Trial with Recruitment and Enrollment, Enhancing Access for Immunocompromised Patients Across the U.S.

MORRISVILLE, NC — July 18, 2024 — Science 37, a leader in enhancing patient access to clinical trials, disclosed the final figures resulting from its partnership with a biopharmaceutical company focused on infectious disease prevention research. Science 37 contributed to the recruitment and enrollment of an immunocompromised patient cohort for the sponsor’s Phase 3 trial.

Leveraging 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 timeline, averaging 65 patients per month. As the top-enrolling site, Science 37 successfully randomized and treated 42% of the cohort while achieving significant geographic, socio-economic, and cultural diversity among participants.

"Depending on the rarity of the condition or sensitivities of the target patient population, some studies are inherently more difficult to recruit and enroll," said Dr. Debra Weinstein, VP of Internal Medicine and Principal Investigator at Science 37. “The complex nature of this study underscores Science 37’s ability to meet challenging clinical trial demands while enhancing patient access and care for vulnerable populations in a fully decentralized manner.”

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 industry-leading flagship Virtual Site, the Metasite™, as part of an accelerated patient access offering. For more information, please visit www.science37.com.

About Science 37

Science 37’s mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; the Metasite™ and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by a proprietary technology stack with in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. 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

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Science 37 Quickly Impacts Performance in Under-Enrolling Clinical Trials

Nearly 20 studies have successfully leveraged Science 37's medical and operational expertise to boost patient recruitment and enrollment activities

RESEARCH TRIANGLE PARK, N.C., June 27, 2024 — Science 37, a leader in enhancing patient access to clinical trials, has been added to over 20 studies that were lagging in recruitment, helping them to trend back towards their projected targets. Leveraging its proprietary Virtual Site and Patient Recruitment solutions, Science 37 efficiently identified, recruited, medically qualified, and enrolled patients without geographic restrictions.

"Enrollment delays can be costly and create immense pressure to deliver results,” commented Brian Smith, Senior VP of Project Delivery at Science 37. “Traditionally, study teams address this by starting up more sites and/or adding patient recruitment. However, today's study teams need solutions that expand patient access to their study regardless of their location. Science 37 provides access to patient populations that no traditional site can match."

Science 37 has successfully supplemented enrollment in a variety of studies, including Phase 2 through Phase 4 and Observational trials across therapeutic areas such as Hematology, Hepatology, Infectious Diseases, CNS, Oncology, and Rare Diseases like Primary Sclerosing Cholangitis and Fragile X Syndrome.

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 industry-leading flagship Virtual Site, the Metasite™, as part of an accelerated patient access offering. For more information, please visit www.science37.com

About Science 37

Science 37’s mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; the Metasite™ and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by a proprietary technology stack with in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. 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

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Science 37 Surpasses Enrollment Goals, Accelerates Phase 2 Rare Disease Clinical Trial

Science 37 Enrolls 21% of Study Participants at 11x the Speed of Traditional Research Sites Through its Virtual Site and Patient Recruitment Solutions
 

RESEARCH TRIANGLE PARK, N.C., June 12, 2024—Science 37 Holdings, Inc., a leader in enhancing patient access to clinical trials, 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 an ongoing Phase 2 trial in patients with Cholestatic Pruritus. 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.

“Traditional recruitment methods are geographically limited, whereas Science 37 can recruit and enroll patients located anywhere, not just within a certain travel radius of a trial site. This significantly broadens the pool of qualified participants, which is vital for rare disease research,” explained Erica Prowisor, SVP of Patient and Provider Networks at Science 37.

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 industry-leading flagship Virtual Site, the Metasite™, as part of an accelerated research offering. For more information, please visit www.science37.com.

About Science 37

Science 37’s mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; the Metasite™ and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by a proprietary technology stack with in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. 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

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Science 37 Undergoes Successful FDA Inspection, Marking Major Milestone in Virtual Site Quality Assurance and Compliance

Science 37’s Virtual Site Model for Clinical Research Impresses in First-of-its-Kind FDA Inspection

RESEARCH TRIANGLE PARK, N.C., May 13, 2024—Science 37 Holdings, Inc. today 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.

“This is likely the agency's first encounter with the fully decentralized clinical site model and we are proud that the nearly two weeks of inspections left them with a very positive impression. Working in a highly regulated environment, Science 37 prioritizes regulatory compliance and integrates quality into every part of its operations,” said Irena Lambridis. “This inspection is a demonstration of our daily commitment to doing high-quality, auditable, submission-level research, and being inspection ready at all times. Earning the confidence of FDA inspectors sends a powerful message to study sponsors and CROs in need of quality, compliant data and research acceleration,” she added.

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.

To learn more about the Science 37 Metasite™, please visit www.science37.com.

About Science 37

Science 37’s mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; the Metasite™ and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by a proprietary technology stack with in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. 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
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