PharmaPros Dataflow ManagerT Solution Benefits Study At Paradigm Spine

Main Category: Clinical Trials / Drug Trials
Also Included In: Bones / Orthopaedics;  IT / Internet / E-mail
Article Date: 18 Sep 2008 - 5:00 PDT

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PharmaPros, a technical consulting and solutions provider specialising in data and workflow management for clinical trials, announced that it has entered into an agreement with Paradigm Spine, a worldwide provider of non-fusion and fusion spinal implant solutions with headquarters in New York and Wurmlingen, Germany, implementing the company's automated trial management solution, Dataflow ManagerT.

With the implementation of Dataflow Manager, Paradigm Spine will have one central interface through which to view and manage all of the clinical information for their clinical trials, including clinical data, site performance metrics, regulatory documents, medical images, reimbursement data, and the ability to export integrated clinical data on-demand for ins-stream analysis.

Dataflow ManagerT is a first-in-class automated trial management solution that provides in-stream access to study status across multiple disparate systems and vendors used to manage today's complex trials. Dataflow Manager automatically tracks the status of a trial against every data source in the study, (Labs, CRFs, EDC, IVRS, CTMS, ePRO, Images) and acts as a collaboration portal for inter-departmental groups and external vendors to utilize a holistic in-stream workflow. Data conflicts between sources/systems area automatically tracked and identified for reconciliation. With real-time access to data "readiness" at the sites, project teams can proactively manage the effective and timely flow of data throughout the trial.

"Paradigm Spine has been a forward-thinking PharmaPros client since 2005, and we are truly excited to be able to offer this solution. Paradigm Spine has challenged us to think about data in new ways, and we are happy to return the favor with this new solution" said Peg Regan, CEO of PharmaPros Corporation.

With Dataflow Manager, Paradigm Spine will now be able to track coflexT reimbursement claims activities, browse site regulatory documents for pre-audit preparations, adjudicate site payments based on performance, and extend the in-stream workflow out to the investigator sites. Paradigm Spine statisticians will also be able to export integrated clinical data on-demand for in-stream analysis. PharmaPros will is also providing a Data Lifecycle Manager to assist the Paradigm Spine trial managers working with aggressive timelines for interim-analysis and PMA filing.

"With the different data we are tracking and reporting on, we now have a solution in Dataflow Manager that will allow us to automate our best practices, supports a data 'lifecycle' approach, and enables our study teams to manage the performance of our investigator sites more proactively than we were able to prior to Dataflow Manager. At Paradigm Spine, we have a philosophy of being data-driven, and Dataflow Manager allows us to stay true to our philosophy" said Marc Viscogliosi, CEO of Pardigm Spine.

About PharmaPros Corporation

PharmaPros Corporation is a technical consulting and solutions provider specializing in data and workflow management for clinical trials. Through its proprietary processes and tools, the company provides services to support the entire data lifecycle- enabling sponsor companies to effectively manage complex trials with multiple vendors and systems. PharmaPros was founded in 1996 and is headquartered in Cambridge, Massachusetts.

PharmaPros Corporation