Delivering Superior Client Results
NAMSA’s Medical Research Organization (MRO) services are designed around one goal: achieving success for clients.
Our teams of testing, clinical and consulting experts not only respond quickly and provide exceptional service, but they also dedicate themselves to assisting customers overcome hurdles and mitigate development concerns by delivering proven strategies and solutions. We consistently go above and beyond to provide the best-fit, high-quality and cost-efficient strategies possible to achieve expedited results for each and every global client.
Here’s what just a few clients are saying about our world class services:
ICHOR Vascular, Inc., a start-up firm focused on the treatment of Peripheral Arterial Disease (PAD) and Limb Ischemias, partnered with NAMSA for the development of the ICHOR Panacea Vascular Embolectomy Catheter System. Operating as a virtual start-up, ICHOR was tasked with the challenge of bringing a 510(k) device to the U.S. marketplace with limited development and regulatory knowledge, restricted resources and a desire to make a timely exit following clearance.
ICHOR, by applying NAMSA’s MRO Program throughout the development continuum, achieved a 30 percent savings in timelines while also shaving off $26M in costs throughout the development lifecycle.
Biom’Up®, a European-based medical device firm focused on collagen-based absorbable medical products for biosurgery, recently sought to obtain its first Class III Investigational Device Exemption (IDE) and Premarket Approval (PMA) in the United States.
Requiring a proven, results-oriented development partner that could provide device testing, preclinical capabilities, clinical trial management and regulatory strategy under one roof, Biom’Up ultimately identified NAMSA as their trusted Clinical Research Organization (CRO) partner. This decision was based on NAMSA’s extensive experience in successfully navigating the U.S. FDA and IDE/PMA submission pathways and their proven track record of delivering proactive solutions and communications from project implementation to close-out.
Biom’Up, with the utilization of NAMSA’s MRO® Approach methodology, achieved record-breaking results of $17M in cost savings and 23 months in accelerated timelines.
Through NAMSA’s Medical Research Organization (MRO®) Approach, clients around the world are realizing multiple time and cost efficiencies throughout all phases of medical device development.
Heraeus, a German-based services firm focused on providing innovative solutions to medical technology companies, recently partnered with NAMSA to conduct a pre-clinical development program. Utilizing NAMSA’s anatomic/bioskills services, multiple successes were achieved throughout, including significant acceleration of product development timelines and cost savings.
CVRx®, a Minneapolis-based cardiovascular medical device company, is dedicated to the development of proprietary active implantable technology for the treatment of high blood pressure and heart failure.
CVRx’s one-of-a-kind product, the Barostim neo™, is currently CE marked in Europe. The organization, requiring quick market access for a successive U.S. heart failure pivotal trial, quickly turned to NAMSA to help accelerate the process. Relying on NAMSA’s clinical and consulting services throughout, CVRx realized both cost efficiencies and time savings as a result of the partnership.