Case Study | Ophthalmology Study | Innovative Quality & Cost Solution

Ophthalmology Study

Innovative Quality & Cost Solution

Issue

A clinical-stage biopharmaceutical company focused on the development of breakthrough therapeutics for ophthalmology indications.

Project

A Phase II multi-center trial requiring quality oversight and management of more than 1250 digital ocular images.

Challenge

How do you ensure the quality of more than 1250 digital ocular images obtained through imaging systems comprised of multiple device and software combinations, and including Optical Coherence Tomography Angiography (OCTA), an emerging ultra-high resolution, three-dimensional imaging modality? The goal of ProTrials was to ensure consistency across all images for:

– Visual characteristics and parameters
– Identification and labelling
– Measurements and size
– Storage and accessibility

Solutions

ProTrials quickly pivoted into an unexpected role formerly provided by a third-party digital ocular image reader. Our project team proactively acquired the technical knowledge, including on OCTA, required to troubleshoot issues with digital ocular image quality. Our CRAs provided technical training and support to investigators and site staff, followed by an in-depth quality check of each digital ocular image prior to Sponsor review.

To meet study timelines and reduce the budget, ProTrials cross-trained team members on the nuances of digital ocular image review. This resulted in team members who could readily step into the process as needed. This also led to a significant cost savings for the Sponsor.

Results

ProTrials delivered accurate digital ocular images paired with cost efficiency, while achieving the study close-out milestone ahead of schedule.

ProTrials has a study team trained and poised for future ophthalmology studies utilizing OCTA.