Post-Market Clinical Studies for Medical Devices

Expertise in Post-Market Observational Studies

NAMSA has extensive expertise in post-market observational studies and medtech clinical research. Our team, led by our Chief Medical Officer, Executive Vice President of Clinical, and former FDA and EU regulatory reviewers, supports the full spectrum of post-market observation trials from protocol development to final study report or publication. We offer comprehensive services along the entire product development path, providing access to highly experienced physicians, regulatory professionals, and clinical research teams.

Depending on your trial requirements, NAMSA can provide a variety of post-market studies. Our services include post-market monitoring to continuously assess the safety and effectiveness of your medical device, post-approval studies mandated by regulatory bodies like the FDA to gather additional performance data, and post-market clinical follow-ups (PMCF) for the EU market to ensure ongoing compliance with safety standards. Our global reach allows us to support both large and small observational studies, ensuring that your post-market needs are met efficiently and effectively. Our services include:

• Site Management and Monitoring: Inclusive of risk-based monitoring to ensure compliance and efficiency
• Data Management: Ensuring accurate and reliable data collection and analysis
• EDC Database Development: Utilizing systems such as iMedNet, Medidata, Zelta, Marvin and more
• Study Management: Handling all technical aspects of your trial
• Electronic Trial Master File (eTMF) Management: Using Veeva Vault for secure and efficient document management
• Project Management: Planning, coordinating, and executing all phases of your trial
• Local Submissions and Trial Registration: Managing regulatory submissions and trial registrations
• Synopsis and Protocol Development: Crafting comprehensive trial protocols
• Medical Writing: Providing protocol writing, investigator brochures, IRB submissions, literature research, clinical study reports, and more

Leveraging Real-World Clinical Data

NAMSA leverages real-world data from sources such as claims and registries to enhance study outcomes, refine clinical guidelines, improve patient care, and support future regulatory submissions. Our expertise ensures thorough safety monitoring and follow-up, providing comprehensive data collection and analysis. We prioritize patient consent and data privacy, maintaining compliance and data integrity throughout the study process.

Our team of biostatisticians have a deep understanding of various data sets and their sources allowing us to set up the right information flow and interpretation, ensuring accurate and meaningful results. With NAMSA, you gain access to a team of clinical experts dedicated to supporting your post-market observational studies with the highest standards of quality and reliability.

Specialists in Medical Devices

At NAMSA, our global expertise and extensive experience in medical device clinical trial management make us the ideal partner for your post-market study. We are adept at navigating the complex regulatory landscape, ensuring that your post-market studies meet all necessary requirements and standards. Our comprehensive understanding of trial design, data management, and analysis allows us to tailor our approach to your specific needs, delivering high-quality, reliable results. By leveraging our deep industry insights and innovative methodologies, we help you generate robust clinical evidence that supports the ongoing safety and effectiveness of your medical device, while also addressing critical business requirements and facilitating market adoption.

Maximize Efficiency by Outsourcing to NAMSA

Partnering with NAMSA means you can efficiently utilize your resources while ensuring the success of your post-market study. We provide the necessary global infrastructure, personnel, and expertise, allowing you to focus on your core competencies such as product development and marketing.

• Our established processes and advanced technological solutions streamline the study process, reducing overall costs and accelerating timelines.
• You can achieve your clinical milestones more quickly and cost-effectively.
• Our global reach and local expertise ensure that your study is conducted efficiently across multiple regions, providing comprehensive data that meets international regulatory standards.

Trust NAMSA to deliver the resource efficiency, expert support, and strategic insights needed to drive your post-market study to success, ensuring your device meets business goals and gains market acceptance worldwide.