Ophthalmology

Decentralized Phase III in Retinal Disease

Focus Area

Ophthalmology

Duration

18 months

Footprint

12 sites, 3 countries

Key Outcome

40% faster enrollment vs benchmark

Overview

A pivotal Phase III program in a retinal indication delivered ahead of timeline through home-based OCT capture and central blinded reading.

The Challenge

What we were asked to solve

A sponsor evaluating a novel intravitreal therapeutic needed 320 patients across a 12-site, three-country footprint — with enrolment historically bottlenecked by imaging visits at specialist centers.

Our Approach

How we delivered it

1Home-based OCT capture using portable devices with encrypted upload to our AI-native CTMS
2Central, blinded reading center with validated grading workflow
3Tele-ophthalmology visits for interim safety review
4e-Consent, ePRO and adaptive stratified randomization via our IWRS/RTSM

Outcomes

40% faster enrollment vs benchmark

First-patient-in achieved 22 days ahead of plan

Enrollment closed 40% faster than sponsor's original benchmark

Missed-visit rate 3.1% (vs 11% program-average benchmark)

Zero Part-11 findings across two sponsor audits

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