Three Essentials for a Good Clinical Study Report
Learn the key elements of a compelling CSR for medical device success with NAMSA’s expert guidance.
Category: Clinical
Embracing Digital Health Technologies: FDA’s New Guidance for Clinical Trials
This blog covers the FDA issued guidance on using digital health technologies for remote data acquisition in clinical investigations, allowing for remote data collection from trial participants.
European Heart Journal: Randomized Controlled Trials Are Not Always the Solution
European Heart Journal Article | Published 13 December 2023 By Sara Finocchietti (NAMSA Senior Strategy Consultant, Clinical) The recent article authored by Siontis et al.1 has made considerable contributions to the ongoing debate concerning the pre-market clinical evaluation of implantable medical devices in Europe, with a particular focus on the cardiovascular domain. The study encompassed seven different … Continued
What is an EDC System and How Does it Support Clinical Trials?
On June 2, 2023, the U.S. Food and Drug Administration (FDA) updated and posted the Final Guidance for Industry and Food and Drug Administration Staff: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.
Your Guide to Biostatistics Outsourcing and Consulting
On March 30, 2023, the U.S. FDA issued draft guidance outlining the use of Predetermined Change Control Plans (PCCPs) for AI/ML software.
Utilization of Least Burdensome Principles during FDA Reviews Benefits Industry
The principles provided in the FDA’s Least Burdensome Provisions Guidance offer useful tools to assess evidence requirements and information on how to effectively navigate the regulatory review process in the United States.
Interventional Oncology: Fast Forward to the Future
As cancer has surpassed cardiovascular diseases and is now the leading cause of death worldwide, its conquest remains elusive despite recent notable progress. Cancer remains an incredibly complex disease, involving virtually every tissue in the body and affecting many genes.
NAMSA ACQUIRES LEADING CLINICAL RESEARCH ORGANIZATION CLINLOGIX TO ENHANCE THERAPEUTIC EXPERTISE AND GLOBAL FOOTPRINT
NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Clinlogix, a leading, Philadelphia-based global clinical research organization. Third in an advancing series, this acquisition follows NAMSA’s purchase announcements of Syntactx and American Preclinical Services (APS) in early 2021.
Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership
NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in new hands.
NAMSA® Acquires Syntactx to Enhance End-to-End CRO Development Solutions, Expanding Medical Device Clinical Research Capabilities and Expertise
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 independent healthcare investment firm ArchiMed’s majority interest purchase of NAMSA in September 2020.
IVD Clinical Trials in the Era of COVID-19: Time to go Virtual?
With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.
Diagnostic Developers Look to EUA Submission to Combat Novel Coronavirus (COVID-19)
China initiated its highest level of emergency response to the COVID-19 outbreak (also referred to as the novel Coronavirus) on 20 January 2020.
MDCG Issues Guidance on Summary of Safety and Clinical Performance under the Medical Device Regulation (MDR)
On 26 September 2019, the Medical Device Coordination Group (MDCG) released final guidance regarding Summary of Safety and Clinical Performance (SSCP), which is intended to serve as a guide for medical device manufacturers and Notified Bodies under Medical Device Regulation (MDR) 2017/745. This guidance provides clear direction on the intent, content and structure of SSCPs … Continued
Three Essentials for Smart IVD Clinical Trial Design
When designing an In Vitro Diagnostic (IVD) clinical trial, there are three major areas that must be considered if manufacturers are to achieve optimal, accurate outcomes: Biostatistics Clinical research conduct Data management While these three clinical research disciplines are interdependent on one other, equal attention should be paid to each of these functions, as outlined … Continued
NAMSA® Launches Market Intelligence Report on Global Medical Device Clinical Outsourcing Trends
TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services is pleased to announce the release of its 2018 Medical Device Landscape Report: Trends and Challenges in Clinical Research Outsourcing. This report, conducted on behalf of … Continued
EU MDR and IVDR Compliance Planning Resources
The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, set forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU. Increased regulatory oversight, expanded clinical evidence requirements, greater requirements for IVD manufacturers and … Continued
CFDA Releases Technical Guidelines for the Acceptance of Overseas Clinical Trial Data of Medical Devices
On January 11, 2018, the China Food and Drug Administration (CFDA) issued “Technical Guidelines for the Acceptance of Overseas Clinical Trial Data of Medical Devices.” These guidelines pertain to the acceptance of overseas clinical trial and evaluation data that are submitted by medical device and In Vitro Diagnostics (IVD) registration applicants in China. It is … Continued
The Value of Randomized Pilot Studies in Demonstrating Patient Safety and Efficacy
Introduction Medical device manufacturers have at their fingertips many types of clinical studies to demonstrate product safety and efficacy, one of which is a randomized, controlled pivotal trial. While there are many routes to initiate these types of trials, sponsors requiring such studies would be wise to first consider conducting a small randomized pilot study … Continued