Clinical Study Report Writing, Reviewing, and Quality Control

The Clinical Study Report (CSR) is the primary record for all clinical trials and is the basis for almost all of medical writing. Understanding the basics of the ICH requirements and knowing various approaches to the traditional problems posed by this document is critical for a medical writer to present the data appropriately and concisely. This workshop presents examples and strategies developed from 15 years in medical writing working for a wide range of pharmaceutical companies.


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