Will provide more efficient clinical trial services for vascular device manufacturers, with the same high quality and faster go-to market
A strategic collaboration has been established to combine the medical registry services of M2S, a division of Medstreaming, with the Contract Research Organization (CRO) expertise of NAMSA, to provide more efficient clinical trial services for vascular device manufacturers.
M2S provides national registry services for the Society for Vascular Surgery Vascular Quality Initiative (VQI) which collects extensive data on vascular procedures, including the devices used, in over 800 U.S. hospitals. VQI registry data has been effectively used for post-approval device surveillance to meet regulatory requirements. Pre-market device trials require additional functions provided by a CRO, with which NAMSA has extensive experience. The M2S/NAMSA collaboration will allow pre-market trials for vascular devices to be conducted more efficiently within an existing registry network but with the full rigor of a standard clinical trial.
Registry-nested trials eliminate duplicate data entry by sites since most data required for such trials are already being collected. The existing network of VQI centers experienced in data entry provides further efficiency, and existing M2S contracts reduce start-up time. Center selection for specific device trials can be optimized by analyzing prior experience. Data analysis, monitoring and report preparation will be performed by NAMSA to meet all regulatory requirements.
Dr. Kenneth Ouriel, NAMSA Chief Medical Officer stated, “NAMSA has provided CRO services for many pre-market vascular device trials. By partnering with M2S, we can use the VQI Registry platform to optimize site selection and data collection efficiency. Both companies share the common goal of helping our clients safely and efficiently deliver innovative medical devices that improve patients’ quality of life.”
“The M2S/NAMSA collaboration is a unique opportunity to join medical registry opportunities with established CRO expertise to transform pre-market device evaluation,” said Dr. Jack Cronenwett, M2S/Medstreaming Chief Medical Officer. “Working together we will be able to provide the custom data and reporting required for device trials while streamlining the data collection and submission process for participating centers.
About NAMSA
Helping medical device sponsors improve healthcare since 1967, NAMSA is the only 100% medical device-focused, full continuum Contract Research Organization (CRO). Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services; NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes. For more information visit www.namsa.com.
June 23, 2021