M2S and NAMSA Collaboration Will Nest Premarket Vascular Device Trials in Registries

June 22, 2021—M2S, a division of Medstreaming, and NAMSA announced a strategic collaboration combining M2S’s medical registry services and NAMSA’s expertise as a Contract Research Organization (CRO) to provide clinical trial services for vascular device manufacturers. The collaboration will allow premarket trials for vascular devices to be conducted more efficiently within an existing registry network but with the full rigor of a standard clinical trial, stated the companies.

As noted in the announcement, 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 > 800 hospitals in the United States. The VQI registry data have been effectively used for postapproval device surveillance to meet regulatory requirements. Premarket device trials require additional functions provided by a CRO such as NAMSA.

According to the companies, registry-nested trials eliminate duplicate data entry by sites because 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.

Kenneth Ouriel, MD, is Chief Medical Officer of NAMSA. Jack Cronenwett, MD, is Chief Medical Officer of M2S/Medstreaming.

“NAMSA has provided CRO services for many premarket vascular device trials,” commented Dr. Ouriel in the companies’ announcement. “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.”

Dr. Cronenwett added, “The M2S/NAMSA collaboration is a unique opportunity to join medical registry opportunities with established CRO expertise to transform premarket device evaluation. 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."