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 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 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.

About Science 37

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

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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

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

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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

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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