Contacts: David Lown, General Manager
(212) 583-0250 ext. 2111 dlown@mcra.com
MCRA , PHARMAPROS ANNOUNCE LAUNCH OF CLINICAL
TRIAL REIMBURSEMENT SOLUTION
Washington, DC - March 3rd, 2008: Musculoskeletal
Clinical Regulatory Advisers, LLC (MCRA), an independent orthopedic
consulting firm focusing on regulatory, clinical, intellectual property
and reimbursement strategy execution, and PharmaPros Corporation,
a consulting services organization focused on innovation in clinical
trials technology solutions, today announced a partnership in support
of MCRA’s unique Clinical Trial Reimbursement Solution (CTRS),
a first-in-class combination of technology, and reimbursement and
clinical trial experience.
The landscape of medical device reimbursement is changing rapidly.
It is clear that the clinical data required for a successful regulatory
approval does not necessarily encompass the clinical data needed for
successful reimbursement of a product. It is also clear that the underlying
reasons for this dynamic are the distinct requirements which need
to be satisfied within the different constituencies. The common bond
for bridging this gap is the design and collection of clinical data,
which accounts for both regulatory and reimbursement considerations.
As such the CTRS is designed to provide integrated strategic and administrative
support during a clinical trial, with the collection of payment and
claims information conducted in parallel with the collection of clinical
data.
“We are excited about the partnership with MCRA. MCRA Reimbursement
has been instrumental in defining the requirements for the reporting
library, and through the use of our technology, in particular the
site collaboration portal, MCRA has had impressive results not only
in securing coverage, but through their focus on supporting the investigator
sites, we have seen consistent improvements in performance at the
sites over the course of a trial” said Peg Regan, CEO of PharmaPros.
The CTRS is broken down into five distinctive areas that provide real
value to the customer: clinical trial support, coverage during the
trial, current & future coding, real time reporting and post approval
commercialization support. In combination with its expertise in regulatory
and reimbursement strategies, MCRA will leverage PharmaPros proprietary
workflow system, which includes extensive data tracking and reporting
capabilities for parallel collection of data for reimbursement and
regulatory submission. PharmaPros and MCRA have co-developed a rich
report library, which can be configured to meet each client’s
unique requirements. During the trial, PharmaPros’ data capture
and reporting environment is used by MCRA advisors to monitor and
direct reimbursement. Coding, coverage, and payment support for sites
and investigator’s billing staff are also an integrated part
of the solution.
David Lown, General Manager of MCRA, said, “In today’s
environment orthopedic clinical trials are required to be comprehensive
& and rigorous for either the FDA or for the continuing medical
education of surgeons. As such, clinical trials in the U.S. today
are producing best in class data; , however the costs associated are
substantial. MCRA believes parallel data collection of reimbursement
information is prudent. We believe and that these practices will be
the standard within 5 years.”
About MCRA, LLC
MCRA was founded in 2003 and provides “first-in-class”
service to its clients through its superior knowledge base, global
surgeon relationships and deeply experienced management team. The
true value of MCRA is the integration of 5 business value creators
– regulatory, reimbursement, clinical, intellectual property
and quality assurance. MCRA places particular emphasis on working
with companies at all stages of development, whether they are single-product
companies or companies with several thousand technologies.
About PharmaPros Corporation
PharmaPros is a consulting services organization committed to innovation
in clinical trials solutions. Its team of industry veterans collaborates
with clients to bridge the gap between clinical trials and clinical
technology through its unique Electronic Data Lifecycle Management
(eDLM) approach. A proven methodology incorporating a proprietary
workflow system with extensive data integration, tracking and reporting
capabilities, eDLM provides a comprehensive view into the completeness
and accuracy of trial data, enabling time critical decision making
throughout the lifecycle of a trial. Working with companies both large
and small, PharmaPros has been delivering services to the Life Sciences
industry since 1996. PharmaPros is privately funded corporation, with
headquarters in Cambridge, MA. www.pharmapros.com
Media Contacts:
David W. Lown
MCRA
Ph: (212) 583-0250 extension 2111
Valerie Harding
Ripple Effect Communications
617-536-8887
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