Northwood, OH – September 1, 2015 – NAMSA, the world’s leading medical research organization, and Fortuna Clinical, a premiere global medical device clinical research organization, are pleased to announce their strategic relationship. As a result of the increase in demand of NAMSA’s clinical services driven by the development of the MRO® Approach, NAMSA and Fortuna Clinical have engaged in a strategic partnership to expand their support and expertise in the cardiovascular arena.
“We are excited to join forces with Dr. Jan Skowronski and Fortuna Clinical so cardiovascular device manufacturers can have the benefit of expert regulatory, laboratory, clinical and medical expertise to cover all facets of patient safety and product efficacy benefits from a single source,” said John Gorski, President and CEO of NAMSA. “Ultimately, this helps accelerate our clients’ product development effort from bench to bedside.”
“Cardiovascular device studies are our passion. In the past I have served as an investigator in multiple device trials and we use our experience and expertise in strengthening NAMSA’s position in cardiovascular clinical trials. We consider Fortuna Clinical to be a CRO ‘with a twist’, as we believe that the best outcome of a clinical study can only be achieved by close collaboration with the investigators, including assistance with case selection and strong clinical support. In all aspects of medicine, but especially in a setting of a clinical trial, each subject should be treated like our own family member,” said Jan Skowronski, MD, MBA and CEO of Fortuna Clinical.
Fortuna Clinical provides NAMSA expertise and access to high growth areas for cardiovascular clinical trial implementation, like Eastern Europe, and will allow for NAMSA to further expand its presence in Western and Central Europe, Asia Pacific and North America. The strategy to join forces with Fortuna continues to reinforce and expand the benefits of NAMSA’s MRO® Approach, reducing the time to market and the cost to launch new medical device products.
“We are thrilled about our partnership with NAMSA, and we are confident that our relationship will position NAMSA as the future market leader in worldwide cardiovascular clinical trials,” said Peter Kopczynski, MBA, COO of Fortuna Clinical.
With this partnership, NAMSA will continue to provide world-class industry leading strategies and services for market approval and market adoption of medical devices for medical device manufacturers. Through its global MRO® Approach, thousands of clients worldwide benefit from NAMSA’s combination of regulatory and quality consulting, laboratory testing and clinical services to solve problems, build value and reduce risk.
About Fortuna Clinical
Fortuna Clinical (http://www.fortunaclinical.com) is a US based company dedicated to supporting cardiovascular device clinical trials in the US and Europe. It provides services for all stages of device development including regulatory, clinical and medical support and post market approval services. It was founded by Jan Skowronski, MD, MBA who has been a leading US endovascular cardiologist. Fortuna Clinical focuses on all cardiovascular studies including coronary, structural heart, peripheral arterial disease, endografts and venous disease devices.
NAMSA (www.namsa.com) is the global medical research organization, providing comprehensive services to advise clients and evaluate the safety and efficacy of medical devices, IVDs and combination products. For nearly 50 years, NAMSA clients have utilized its consulting, testing and clinical services to bring safe and effective therapies to market.
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