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| 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: |
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Clinical Study Reports |
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NDA, PMA, and other regulatory submissions |
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Publications |
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IND Annual Updates |
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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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