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news.Capstone Therapeutics, a biotechnology company, has selected PharmaPros's data lifecycle management solution, Dataflow Manager, for its Phase II study to evaluate the safety and preliminary efficacy of AZX100 in trocar sites of arthroscopic shoulder surgery patients.
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During the trial, Capstone and its service providers will utilize Dataflow Manager as its central interface to track and manage clinical information for the Phase II study.
Using virtual integration, Dataflow Manager will provide an integrated view of study metrics in-stream, including patient data via electronic data capture, safety data, 2D and 3D medical images and image findings data, and laboratory data. Dataflow Manager will also provide Capstone statisticians with on-demand outputs of integrated datasets for in-stream data analysis, said PharmaPros.
The Dataflow Manager solution for Capstone includes a PharmaPros data lifecycle manager who will collaborate with Capstone throughout the study using Dataflow Manager’s interactive reporting dashboards to track data readiness for interim-analysis, ensure timely entry of data at the investigator sites, manage technology vendors and assist project teams in ensuring critical milestones and timelines are being met.
Joan Matusin, senior director of clinical operations at Capstone, said: “We are pleased to be working with PharmaPros and to be using Dataflow Manager. The program interface allows our company to retain the level of control and visibility necessary to ensure successful execution of our studies.”