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A New
York state of MSA
June 2010
EDIT CONNECT
SHARING OPTIONS:
NEW YORK—CLINiLABS has signed a master services agreement
(MSA) to license NewCardio's QTinno cardiac safety analysis software, adding
ECG
services to it drug industry portfolio.
The technology, which enables fully automated cardiac
safety
analyses in cardiac intensive and QT studies, will be used at CLINiLABS' unit
in New York.
In addition, CLINiLABS, a contract research organization
(CRO) that provides clinical drug development services to industry, has signed
a
services work order, including standard operating procedures (SOP) and
validation kits, as well as professional services, so NewCardio, a cardiac
diagnostic and services company, can assist CLINiLABS in developing an ECG core
laboratory.
"This announcement is further evidence of the growing
adoption of QTinno by innovative clinical trial service providers looking to
deliver quality
cardiac safety analysis with higher accuracy and lower
intrinsic variability in a timely and cost-effective manner," says Vincent
Renz, NewCardio's
president and chief operating officer. "Our target customers
are clinical trial service providers looking to deploy our proven technology to
expand
services and grow market opportunities. For CLINiLABS, adding to its
available scope of services by utilizing QTinno accomplished these two
important
goals."
While the financial terms of the agreement have not been
made public, Renz says the MSA,
which sets the foundation for a very integrated
strategic partnership between NewCardio and CLINiLABS, can effectively be
defined in two
components.
"The first and current component is working together to
accelerate the internal
organizational readiness for CLINiLABS to deliver high
quality automated cardiac safety analysis, through QTinno, in a timely and cost
effective manner
as part of their core clinical service offerings," he says.
"This will be facilitated through the delivery of implementation kits and
services, from
senior resources experienced in building and supporting world
class ECG core labs."
Renz
notes that the second component is the actual delivery
of quality cardiac safety analysis as an integrated component of early phase
QT/TQT studies for
CLINiLABS customers.
"QTinno's license model is based on an ECG processing
transaction fee,
which enables CLINiLABS to avoid any upfront license fee,
which could be a detriment to market/customer adoption, as well as price the
services on an
per-ECG basis, which is the current standard pricing model for
the delivery of cardiac safety services by ECG core labs, another means of
facilitating
market adoption," he says. "This license model incents both
parties to work closely together in securing and delivering quality cardiac
safety
services, as the success of NewCardio/QTinno is tied directly to the
success of CLINiLABS in this initiative. CLINiLABS' long term plans include the
development of ECG core lab services based on QTinno's automation, enabling
them to provide a low-cost solution for ECG analysis for all phases of
clinical
drug development."
The relationship will enable CLINiLABS to compete in the
market
for ECG core laboratory services by providing the professional services
needed to integrate ECG core lab functions into CLINiLABS' existing core data
center, which currently serves clinical trials in 33 countries.
Dr. Gary K. Zammit, president and
CEO of CLINiLABS, points
out that NewCardio's QTinno, coupled with its team's history and expertise in
delivering cardiac safety services to leading
pharmaceutical companies, "has
given us an incredible opportunity to expand our service portfolio and deliver
value to our clients. We can now provide
a differentiated and low cost solution
for ECG data analysis to an industry that has been seeking a meaningful
alternative to existing methods for some
time."
As Renz points out, advantages of QTinno are in the
robustness of the technology,
presented through the proprietary approach and
algorithms, as well as the integrated workflow application and experienced
services organization built
by NewCardio to support its customers.
"The underlying technology, driven by our virtual
vector
magnitude lead, iterative curve fitting algorithm and confidence factor has
continuously delivered results which match or exceed the so-called
manual 'gold
standard,' with significantly lower intrinsic variability, shorter
timelines/turnaround and lower cost," he says. "The virtual vector
magnitude
lead presents a lead which contains information from all lead, all beats
thereby providing QTinno access to data from the ECG which has
always been
known to be available, but inaccessible to the human eye.
"QTinno is different from
the other solutions in that it
does not simply automate the manual and/or semi-automatic approaches (i.e.
single lead tangent, global median beat,
etc.), which would result in applying
technology to a inaccurate process, thereby receiving inaccurate result, only
faster," he adds.
Ultimately, Renz says his company will measure its success
with the success of CLINiLABS in their
ability to "secure and deliver quality
cardiac safety analysis services in a more timely and cost effective manner, as
an integrated services
offering, to their drug development clients." Code: E061027 Back |
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