Medical Writing
CTMS and its partner, StatWorks, Inc, have produced numerous study reports, publications, and other study materials. Working to industry standards, like ICH E3 Guidelines or your internal report templates, and under tight timelines, we can help you meet your needs in drafting and finalizing a variety of clinical development documents including:
Clinical Study Reports
NDA, PMA, and other regulatory submissions
Publications
IND Annual Updates
Internal documents or topline summaries
We have successfully written ISS and/or ISE sections of several NDA and EMEA applications that are currently approved for marketing throughout North America.



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