Accelerating Clinical Trial Enrollment & Enhancing Patient Experience

An ophthalmic gene therapy company wanted to find a strategic solution to avoid a common bottleneck: slow site activation, delaying patient enrollment. Traditionally, pre-screening occurs only after clinical sites are fully activated, requiring patients to travel—often long distances—for a screening visit that may ultimately result in disqualification. This process slows enrollment and contributes to a frustrating and burdensome patient experience.

Furthermore, conventional pre-screening methods rely on basic questionnaires or medical record checks rather than protocol-specific clinical assessments. This results in uncertainty about a patient’s eligibility until later in the process, wasting time and potentially losing participants as the disease progresses.

The sponsor and 20/20 Onsite developed a strategic solution to bridge the gap between early interest and full enrollment. This solution required accurate, protocol-specific testing before site activation without a brick-and-mortar clinic. 

20/20 Onsite and the company creatively formed a mobile pre-screening program through our Mobile Vision Clinics (MVCs) designed to conduct in-depth, protocol-aligned clinical assessments at the point of need—even before sites were activated. Our mobile clinics, already fully equipped and staffed by certified technicians, provided key imaging and functional assessments aligned with the trial protocol, using calibrated equipment and SOPs that mirrored site-level standards.

This advanced pre-screening approach included:

• In-person testing aligned with image acquisition and equipment calibration standards.
• Continuous patient interaction during the pre-screen visit allows for observation, optimization, and personalized care improvements.
• National reach that reduced travel burden and allowed assessments to happen at or near the patient’s home, well before local sites were activated.

Our model also enabled our clinical team to observe trends across large cohorts and recommend changes that improved patient experience and data quality trial-wide. 

When the study opened for formal enrollment, 28 out of the first 34 participants (82%) had already been pre-screened and qualified through 20/20 Onsite’s mobile assessments. This unprecedented readiness enabled the sponsor to accelerate enrollment significantly, bypassing site activation and in-clinic scheduling delays. 

Traditional screening processes often required patients to take time off work and travel long distances, only to be turned away. Our point-of-need patient model reduced this burden dramatically. Even when patients weren’t immediately eligible, the lower-friction experience kept them “warm” to the trial—eager to be re-screened as the protocol or disease state evolved. 

Unlike traditional, fixed sites, which see limited patients sporadically, 20/20 Onsite technicians engaged with over 80 patients during that year, allowing patterns and needs to emerge. One example is patients experiencing fatigue during extended imaging procedures.

Our lead technician took the initiative to:

• Suggest reordering the testing sequence to reduce patient fatigue.
• Based on a re-review of the protocol, lubricating eye drops (protocol compliant) were recommended to improve patient comfort and image capture quality.
• Floor navigation markings were added to guide patients through the mobile vision clinic.

The sponsor adopted this recommendation across all trial sites, directly resulting from the volume and consistency of patient interactions enabled by our point-of-need model. 

This case study showcases the transformative impact of mobile, point-of-need clinical trial support. By enabling advanced pre-screening before site activation, 20/20 Onsite helped the sponsor:

• Dramatically shorten enrollment timelines.
• Improve patient experience and retention.
• Ensure protocol compliance.
• Accelerate data collection—ultimately contributing to FDA Fast Track designation.

For sponsors seeking to optimize early-phase clinical trial operations, this approach represents a powerful new standard in patient-centric research delivery.