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A New York state of MSA
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."