Veristat Resource Library
Agile Medical Writing Support for an NDA
Veristat supported a clinical-stage biotech organization focusing on CNS disorders to support the team's biostatistics and programming needs for its clinical trial. The relationship expanded to include support for developing a New Drug Application (NDA), with one critical element being medical writing for the Summary of Clinical Safety (SCS) document, having an aggressive timeline. Through a strategically developed timeline and workflow, and expert medical writing, we significantly reduced the client review burden, and the client was able to submit the NDA a day ahead of schedule.download
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