The Clinical Trial at Your Doorstep: A New Era of Patient Access

MORRISVILLE, NC – December 02, 2025 – The clinical research industry, long defined by brick-and-mortar hospitals and academic centers, is undergoing a fundamental shift. This transformation was cast into the spotlight as Science 37, a pioneer in decentralized clinical trials, received the 2025 Clinical Trials Arena Site Innovation Award for R&D Leadership. The recognition, powered by independent research from the analytics firm GlobalData, honors the company’s Direct-to-Patient (DtP) Clinical Trial Site—a model that is not merely an incremental improvement but a radical reimagining of how new therapies are tested and brought to market.

For decades, the clinical trial paradigm has remained largely unchanged: patients travel, often at great personal cost and inconvenience, to a physical research site. This model inherently limits participation to those living near major medical centers, creating a significant barrier to access and contributing to a chronic lack of diversity in study populations. Science 37’s award-winning approach dismantles this geographic constraint by conceptualizing the “site” not as a building, but as a single, nationwide, FDA-inspected operational hub that brings the trial directly to the patient’s home.

The Decentralized Revolution Takes Center Stage

At the heart of Science 37’s innovation is its “Metasite™,” a comprehensive virtual site model that orchestrates every aspect of a clinical trial remotely. This isn't simply about providing a mobile app; it's a full-stack service that combines a proprietary technology platform, in-house clinical expertise, and sophisticated logistics. The company operates as a single entity across all 50 states, leveraging nationwide medical licensure to manage studies seamlessly from coast to coast.

This is made possible through a combination of its Network Oriented Research Assistant (NORA®) platform and a dedicated team of professionals. Patients use the mobile platform for telemedicine visits, data reporting, and communication, while board-certified investigators oversee the study remotely. Crucially, a network of in-house, research-grade nurses conducts study visits directly in participants' homes. These highly trained professionals manage everything from the shipment and administration of temperature-controlled investigational drugs to performing complex assessments, including in-home intravenous infusions.

“Receiving the Site Innovation Award reflects the transformative impact of our Direct-to-Patient Site,” said Tyler Van Horn, CEO of Science 37, in a recent statement. “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.”

For pharmaceutical sponsors, this model streamlines operations significantly. Instead of managing dozens of individual sites, each with its own contracts, staff, and regulatory submissions, they can partner with Science 37 under a single contract and budget. The company consolidates regulatory requirements into a single Form 1572 and one Institutional Review Board (IRB) submission, drastically reducing administrative complexity and accelerating trial start-up times.

Breaking Down Barriers to Research and Equity

The most profound impact of this decentralized model is on patient access and health equity. By eliminating geography as a barrier, Science 37 expands the potential participant pool from the estimated 8% of the U.S. population living near a traditional trial site to nearly 100%. This opens the door for patients in rural areas, individuals with mobility challenges, and those from underrepresented communities to participate in cutting-edge research.

The performance data speaks for itself. In an FDA-inspected pivotal Phase 3 asthma trial, Science 37 operated as the top enrolling site, contributing 28% of all participants. For a pediatric Phase 3 study in Fragile X Syndrome—a population often facing high dropout risks—the company enrolled 25% of all participants while maintaining an impressive 94% retention rate. The model’s efficiency is further highlighted in a Phase 4 narcolepsy study, where it was responsible for 55% of total enrollment, enabling the sponsor to complete recruitment ahead of schedule. Similarly, in a pivotal Phase 3 trial for primary biliary cholangitis (PBC), the company enrolled 47% of all U.S. participants.

These figures are not just numbers; they represent a fundamental shift in recruitment velocity and diversity. By meeting patients where they are, the DtP model reduces the significant burden that often leads to high dropout rates, thereby improving data integrity and increasing the likelihood of a trial’s success. It transforms participation from a demanding obligation into a more integrated part of a patient's life.

Setting a New Standard with Regulatory Trust

While the concept of decentralized clinical trials (DCTs) gained significant momentum during the COVID-19 pandemic, questions surrounding data quality, patient safety, and regulatory oversight have persisted. This is where Science 37 has established its most critical market differentiator. It is the first and, to date, the only company to operate an FDA-inspected Direct-to-Patient Clinical Trial Site.

This is not a minor detail. The company has successfully completed multiple FDA inspections across several pivotal Phase 3 trials, with every inspection resulting in a “No Action Indicated” (NAI) outcome. An NAI classification is the best possible result, signifying that inspectors found no objectionable conditions or practices. These successful inspections, including one in April 2025 for the asthma study and another in October 2025 for the PBC trial, provide powerful, third-party validation of the model's integrity and compliance.

This regulatory track record effectively sets a new gold standard for trust and quality in the decentralized space. It demonstrates to sponsors and regulatory bodies worldwide that a fully remote trial can be conducted with the same, if not greater, rigor and oversight as a traditional site-based study. As the FDA continues to refine its guidance on DCTs, with final recommendations issued in September 2024, Science 37’s proven compliance provides a clear blueprint for how to execute these complex trials successfully.

This level of regulatory confidence is crucial for an industry where risk management is paramount. It de-risks the adoption of decentralized models for pharmaceutical companies, encouraging broader implementation and accelerating the modernization of clinical development. As the industry moves beyond the pandemic-driven necessity for remote solutions, models that can prove their robustness and quality will undoubtedly lead the way. Science 37's success with the FDA provides a powerful proof point that the future of patient-centric research is not only possible but is already here and meeting the highest standards of regulatory scrutiny.