Transforming Ophthalmic Assessments for a Mid-Trial Protocol Change

A biopharmaceutical company was conducting four simultaneous clinical trials to complete enrollment by early 2025. Midway through, a new FDA mandate added ophthalmic assessments to the study protocols. This sudden requirement created an urgent need to equip 65 sites with the proper tools, certifications, and processes to conduct rigorous eye exams, including visual acuity, OCT, and fundus imaging, without delaying the trial.

However, ophthalmic evaluations are highly specialized. Each site would now need to have on-site or contract externally for:

• Certified technicians trained on protocol-specific procedures.
• Calibrated and protocol-aligned equipment installed and verified.
• Customized project materials for both site staff and participants.

Complicating matters, 20/20 Onsite joined the trial after it was already underway. This meant working within already-established protocol windows and ensuring patient visits occurred on time—some within just 2–4 days of receiving their information. Most trials wouldn’t expect to see a participant for 90–120 days post-initiation. The sponsor needed a partner who could move fast and deliver high-quality without compromise. 

The company partnered with 20/20 Onsite to deploy point-of-need ophthalmic services rapidly and seamlessly across all 65 participating sites. 20/20 Onsite’s standing relationship with the reading center enabled faster certification times and familiarity with the submission technology platform and review process.

Over an intensive 8-week startup window, 20/20 Onsite accomplished the following:

• Simultaneous Equipment & Technician Certification: Each 20/20 Onsite clinic was outfitted with protocol-specific ophthalmic equipment, including:

  • ETDRS Visual Acuity Testing
  • Ultra-Widefield Fundus Imaging
  • Optical Coherence Tomography (OCT)

• All devices were installed, calibrated, and certified; technicians underwent study-specific certification processes to ensure consistency and compliance. 

• Customized Protocol Implementation: Every clinic setup was tailored to the study's unique protocol requirements, allowing for uniform data collection across all locations.

• Operational Readiness: In parallel with clinical certifications, 20/20 Onsite developed:
  • Project management plans
  • Site- and subject-facing materials

  • Onboarding resources for investigators and coordinators

• They also held individual meetings with each site to establish strong working relationships immediately and clarify scheduling and documentation workflows.

• Rapid Response to Protocol Mandates: Because the trial was ongoing, 20/20 Onsite took immediate action to:

  • Collect data on the status of current participants and their progression in the trial
  • Identify where each participant was in the study
  • Determine which participants require ophthalmic exams and when
  • Schedule visits quickly to meet protocol windows—often within days

Within just 8 weeks, 20/20 Onsite was fully operational across 65 sites and began patient visits immediately. Notably:

• 11 participants were seen in the first 60 days of the partnership
• The standard trial ramp-up period (90–120 days) was cut in half

This approach ensured no participant missed their protocol-mandated window due to ophthalmic scheduling constraints. 

Despite the rapid timeline, quality was never compromised. All sites delivered high-fidelity imaging and data thanks to:

• Standardized technician training
• Calibrated and certified imaging equipment
• Uniform procedures across sites 

By acting as a single ophthalmic services provider across all 65 sites, 20/20 Onsite:

• Simplified contracting and scheduling
• Reduced administrative burden for the sponsor
• Boosted investigator engagement through clarity and consistency

Faced with a mid-trial protocol shift and tight FDA compliance timelines, the sponsor turned to 20/20 Onsite to deliver specialized ophthalmic assessments at scale—and fast. In just eight weeks, 20/20 Onsite mobilized certified teams and equipment across 65 sites, onboarded site staff, and began seeing patients, often within days of receiving assignments.

This partnership didn’t just save the timeline; it elevated the standard of care and provided a repeatable model for how decentralized trial logistics can meet even the most urgent and technical demands.