M2S and NAMSA collaboration to integrate pre-market vascular device trials into registries

NEW YORK–(COMMERCIAL THREAD) – A strategic collaboration has been established to combine the medical registry services of M2S, a division of Medstreaming, with the expertise of NAMSA’s Contract Research Organization (CRO), to provide services of more effective clinical trials to manufacturers of vascular devices.

M2S provides national registry services for the Society for Vascular Surgery Vascular Quality Initiative (VQI) which collects detailed data on vascular procedures, including devices used, in more than 800 US hospitals. Data from the VQI registry has been used effectively for post-approval monitoring of devices to meet regulatory requirements. Pre-market device testing requires additional functions provided by a CRO, with which NAMSA has extensive experience. The M2S / NAMSA collaboration will allow pre-market trials of vascular devices to be conducted more efficiently within an existing registry network, but with all the rigor of a standard clinical trial.

Nested registry trials eliminate duplicate data entry by sites since most of the data required for such trials is already collected. The existing network of VQI centers experienced in data entry offers increased efficiency and existing M2S contracts reduce start-up time. The selection of the center for specific device testing can be optimized by analyzing previous experience. Data analysis, monitoring and reporting will be performed by NAMSA to meet all regulatory requirements.

Dr Kenneth Ouriel, Medical Director of NAMSA, said: “NAMSA has provided CRO services for numerous pre-market vascular device trials. By partnering with M2S, we can use the VQI registry platform to optimize site selection and data collection efficiency. The two companies share the common goal of helping our customers safely and efficiently deliver innovative medical devices that improve the quality of life for patients.

“The M2S / NAMSA collaboration is a unique opportunity to join medical registry opportunities with established CRO expertise to transform pre-market device assessment,” said Dr. Jack Cronenwett, Medical Director of M2S / Medstreaming. “By working together, we will be able to provide the personalized data and reports required for device trials while streamlining the process of collecting and submitting data for participating centers.

About M2S / Medstreaming

Medstreaming is a medical informatics company specializing in workflow productivity technology, registry development and clinical imaging services. M2S, a division of Medstreaming, is a leading provider of online registry services for medical companies that enable users to analyze and compare their clinical performance to improve healthcare. Medstreaming has created specialized EMR systems that effectively integrate structured data entry into the workflow process to enable data mining and analysis. Together, Medstreaming-M2S provides a comprehensive real-world evidence platform that delivers innovative technology and services to healthcare providers, medical companies and industry partners to improve care, conduct research and effectively assess device performance. For more information visit www.m2s.com and www.medstreaming.com.

About NAMSA

Helping medical device sponsors improve healthcare since 1967, NAMSA is the only full-continuum contract research organization (CRO) focused on medical devices. With its global regulatory expertise and deep therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, delivering only the most proven solutions to advance customers’ products throughout the lifecycle. development in an efficient and cost-effective manner. Medical device tests; regulatory, reimbursement and quality advice; and clinical research services; NAMSA is the industry’s premier trusted partner for successful development and commercialization results. For more information visit www.namsa.com.

About Geraldine Higgins

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