What To Know
- Relying on the latest technologies, a client-focused approach and leveraging long-standing, trusted relationships with regulatory agencies and investigational sites, together, we will provide a range of services and level of quality unsurpassed in the global CRO industry.
- As the pioneer of the medical device testing industry, NAMSA provides testing services to Sponsors, in addition to quality, reimbursement, clinical research and regulatory solutions.
January 5, 2021
NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of New York-based CRO, Syntactx.
This acquisition follows an independent healthcare investment firm ArchiMed’s majority interest purchase of NAMSA in September 2020.
Syntactx, founded in 2010, has a rich history and proven track record of synthesizing clinical evidence for global medtech Sponsors to enable broad market adoption and commercial success of innovative medical products. Having enrolled over 200,000 trial subjects within the last ten years, Syntactx possesses significant expertise in complex interventional medical device trials and a deep-rooted understanding of enrollment obstacles and regulatory challenges and obligations.
As the pioneer of the medical device testing industry, NAMSA provides testing services to Sponsors, in addition to quality, reimbursement, clinical research and regulatory solutions. The CRO’s end-to-end development services are shown to help Sponsors successfully address varying global requirements, including recently expanded criteria for medical device research and conduct (e.g. MDR/IVDR), resulting in increased regulatory oversight and clinical evidence requirements.
“This is a very exciting day for NAMSA, and I couldn’t be more pleased that Syntactx is joining the NAMSA family,” stated John Gorski, President and CEO. “Not only are our values and cultures well-aligned, but both organizations have a strong commitment to enhancing patient healthcare by safely and judiciously helping clients deliver innovative, life-changing medical devices to the global marketplace,” he concluded.
Most notably, NAMSA’s acquisition of Syntactx will enhance the company’s already robust cardiovascular-focused regulatory consulting and clinical research solutions, while expanding Electronic Data Capture (EDC), core lab imaging, safety and physician consulting service offerings. These areas are key to further strengthening NAMSA’s rich history of assisting Sponsors to proactively tackle development challenges head-on, achieve commercialization success and positively impact patient lives.
“Syntactx is very proud to join NAMSA, a long-recognized industry leader in CRO medical device development and clinical research services,” stated Dr. Kenneth Ouriel, President and CEO of Syntactx. “Syntactx’s corporate goals are wholly aligned with those of NAMSA. Relying on the latest technologies, a client-focused approach and leveraging long-standing, trusted relationships with regulatory agencies and investigational sites, together, we will provide a range of services and level of quality unsurpassed in the global CRO industry.”