Regulatory Writing

Clinical Study Reports

Providing Clinical Study Report (CSR) preparation from start to finish. Tanager Medical Writing will generate a full CSR that is compliant with ICH guidelines from statistical tables and listings. A high-level summary based on preliminary data, can also be prepared. Services include document management through review cycles, with incorporation and adjudication of all reviewer comments.



A generic example of a Clinical Study Report Synopsis, and a Clinical Study Report, are available,

Clinical Protocols

A generic Protocol Synopsis Sample is available (here). Templates and other samples may be made available by request.

Investigator Brochures



Clinical Safety Summaries & Integrated Summary of Safety



Nonclinical and Tabulated Summaries



Safety Narratives

   Samples available by request

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