PharmaPros Dataflow ManagerT Solution Benefits Study At Paradigm Spine

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