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 (here).

Clinical Protocols

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

 

Investigator Brochures

Clinical Safety Summary and Integrated Summary of Safety

Nonclinical and Tabulated Summaries

Safety Narratives

 

     Samples available by request

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