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Next Generation Solution in Clinical Trials for the Life Science Industry

By Drew Barrows
Sr. Editor

March 31, 2011

PharmaPros, a technical solutions provider have been specializing in data and workflow management for clinical trials for over a decade with its first-in-class product, Dataflow Manager™, the company is pioneering the next generation in workflow technology to support the entire data lifecycle for clinical trials. This past spring Peg Regan, PharmaPros President, and Nick Neri, VP of Technology, shared this innovative solution for managing data via virtual integration technology and operational data workflow across disparate systems/data sources at the Cambridge Healthtech Institute's Electronic Data in Clinical Trials conference. 
 
This novel approach is successfully in place in studies across the country. One example would be Capstone Therapeutics 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. Joan Matusin, RN, Senior Director, Clinical Operations at Capstone Therapeutics comments that ”the program interface allows our company to retain the level of control and visibility necessary to ensure successful execution of our studies.”
 
Thus Bridging the gaps that are inherent in today’s next generation landscape requires next generation processes that ensure data are being acquired as expected, that vendors are delivering results, that sites are functioning, that cross functional teams are focused on their objectives and not duplicating efforts, and that data problems are detected early and resolved well before analysis needs to be conducted. Regan adds that “Dataflow Manager, which will be utilized as Capstone’s trial management interface…achieves 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.
 
A PharmaPros Data Lifecycle Manager collaborates 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.
 
The eDLM solution is NOT the data management of the past where data comes in, data gets processed, queries go out, and databases get locked - central to a study, but not eDLM. A holistic data management reaching across data sources identifies downward trends/indicators requiring additional support at sites, managing vendors to reconcile data issues thus ensuring performance to the study timelines . This complete, current knowledge of the different types of data is the answer to reduced study delays advancing the race to deliver quality products for well being of humanity.

 
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