NAMSA provides specialized report writing, manuscript submission and evidence communication services to support clinical and regulatory objectives. In partnership with NAMSA’s Biostatistics, Clinical and Regulatory Teams, our medical writers organize, interpret and present data in an accurate, professional and trusted manner that is highly recognized and trusted by global regulatory entities.
Additionally, NAMSA offers Clinical Evaluation Report (CER) and Performance Evaluation Reports (PER) writing services. Our dedicated team of 45+ CER/PER experts perform approximately 600 CERs/PERs annually. They are expert at defining and prioritizing which reports are required to comply with the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), MEDDEV 2.7.1 rev. 4 and a multitude of other regulatory guidelines. When working with NAMSA, Sponsors are also provided a personalized plan to help guide future compliance activities.
Other Common Report and Manuscript Writing Assignments
- Interim and final clinical reports
- Sections of interim and final clinical reports
- Co-authorship to journal submissions
- Literature summaries
- Expert opinion letters
- Review and editing
- Regulatory submissions
- Advisory panel presentations
Are NAMSA’s services a good fit for your needs? Contact a NAMSA representative +1-866-666-9455 (+1-419-666-9455 if you’re outside the US) or through our site contact form.