Dry Eye Disease Case Study
SITUATION
A rapidly growing, biopharmaceutical company, dedicated to developing innovative therapies and novel biologics for rare and underserved ocular disorders, aggressively pursues new treatments for ocular surface diseases, retinal diseases as well as a gene therapy pipeline.
Study Phase: III
Indication: Dry Eye Disease
Sites: 25
Services: Full Service
CHALLENGES
- To initiate 25 sites in the US within 4 weeks
- To randomize 250 patients within 6 weeks
- To clean all data within 1 week of Last Patient Out
- To deliver Top Line Results within 3 weeks of Last Patient Out
TFS SOLUTION
TFS leveraged site intelligence, having access to site performance metrics; to ensure the study was initiated and closed within the unmissable timelines.
The strong site relationships and review of historical data collected by TFS supported a thorough analysis for site suitability. Data analyzed included metrics relating to recruitment, start up performance, quality of study delivery and level of commitment and staffing.
TFS also leveraged previous reputation of project delivery with the sponsor, by providing a cohesive full service team with a deep understanding of the indication and aggressive strategy need.
CLIENT ADVANTAGE
As well as the sponsor/CRO ongoing trusting relationship, the sponsor benefitted from the very experienced ophthalmology leadership team plus the close relationships with the sites. Thus saving time and cost on initial feasibility, resulting in achieved milestones. The delivery of Top Line Results enabled the sponsor to progress their Dry Eye pipeline as projected.
