CRO Clinipace is providing electronic data capture, clinical monitoring, site management, biostatistical consulting and regulatory document management for Inspire Pharmaceuticals for Phase 2 clinical trials of an eye treatment called AzaSite. The CRO will use its web-based software, Tempo, according to a local press report.
The drug is approved for use on cases of bacterial conjunctivitis. Inspire now seeks approval for use on the ocular disease blepharitis, which is characterized by inflammation of the eyelids.
Two trials are underway: One is a randomized trial at approximately 30 sites evaluating the safety and efficacy of a two-week treatment with the drug compared to placebo in approximately 300 blepharitis suffers. The second trial will study four weeks of treatment.
Clinipace bills itself as a digital CRO. Its Tempo software for clinical trials and registries combines data capture and study management, according to the company. Functions include enrollment, randomization, and data collection and cleaning on the data capture side, and training, monitoring, management and reporting n the study management side.
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