Cambridge, MA, March 3, 2009 PharmaPros, a technical solutions provider specializing in data and workflow management for clinical trials, today announced that Capstone Therapeutics has selected the company’s data lifecycle management solution, Dataflow Manager, for its Phase 2 study to evaluate the safety and preliminary efficacy of AZX100 in trocar sites of arthroscopic shoulder surgery patients.
Capstone Therapeutics (trade name of OrthoLogic Corp.) is a biotechnology company committed to developing a pipeline of novel therapeutic peptides aimed at helping patients with under-served medical conditions. “PharmaPros and Capstone share philosophical synergies from our multiple trial engagements,” said Peg Regan, CEO of PharmaPros. “Dataflow Manager, which will be utilized as Capstone’s trial management interface, underscores this joint philosophy: achieving higher quality data through in-stream data access and maintaining control of the data throughout its lifecycle.” 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 2 study. Using virtual integration, Dataflow Manager will provide an integrated view of study metrics in-stream, including patient data via EDC, safety data, 2D & 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.
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.
“We are pleased to be working with PharmaPros and to be using Dataflow Manager,” said Joan Matusin, RN, Senior Director, Clinical Operations, Capstone Therapeutics. ”The program interface allows our company to retain the level of control and visibility necessary to ensure successful execution of our studies.” Dataflow Manager is a first-in-class solution that facilitates in-stream Data Lifecycle Management, the next generation of managing clinical trials data. Using virtual integration and process automation, Dataflow Manager empowers companies to proactively manage clinical trials across multiple data systems and vendors, and against expected milestones and timelines.