Paradigm Spine Advances Data-Driven Goals with PharmaPros Dataflow Manager

September 22, 2008
Company News Release

PharmaPros, a technical consulting and solutions provider specializing in data and workflow management for clinical trials, announced that Paradigm Spine, a provider of non-fusion and fusion spinal implant solutions, has selected the company's automated trial management solution, Dataflow Manager, for its coflex IDE clinical study, and future studies in the Paradigm Spine pipeline.

PharmaPros continues successful launch of Dataflow Manager in new and existing clients’ clinical trials

Cambridge, MA, September 22nd, 2008; PharmaPros, a technical consulting and solutions provider specializing in data and workflow management for clinical trials, today announced that Paradigm Spine, a provider of non-fusion and fusion spinal implant solutions, has selected the company’s automated trial management solution, Dataflow Manager, for its coflex IDE clinical study, and future studies in the Paradigm Spine pipeline.

Dataflow Manager is a first-in-class automated trial management solution that provides in-stream access to study status across the multiple systems and vendors being used to manage today’s complex clinical 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 through which study teams can manage trials with an integrated view
of the study data.

With Dataflow Manager, Paradigm Spine will have one central interface through which to track and manage all of the clinical information for their coflex IDE study, including clinical data, safety data, medical images, site performance metrics, regulatory documents and reimbursement data.

“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 managing the lifecycle of 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 coflex 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.

The Dataflow Manager solution will be supported by a PharmaPros Data Lifecycle Manager to assist Paradigm Spine in managing its aggressive timelines for interim-analysis and PMA filing.

”After careful evaluation of our internal needs and capacity, along with a thorough analysis of available external options, we found Dataflow Manager to provide a level of in-stream visibility unmatched by other solutions. In Dataflow Manager, we now have a solution that allows us to automate our best practices, manage the performance of our investigator sites more proactively, and effectively control costs. At Paradigm Spine, we have a philosophy of being data-driven, and Dataflow Manager allows us to stay true to that vision” said Marc Viscogliosi, CEO of Paradigm 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.