Clinical Trial Reports and Regulatory Documents Prepared

ICH Guideline E3

The content and format of Clinical Trial Reports (Clinical Study Reports) is guided by the ICH Guideline E3 on Structure and Content of Clinical Study Report, which was approved in 1996. Since then regulatory authorities and the industry have worked to refine some of its ambiguities and redundancies, and have allowed the template to evolve into a well-structured, highly intuitive format for the presentation of clinical results.

Our medical writers are highly experienced in producing ICH-GCP compliant Trial Reports according to the ICH E3 format.

Phases 1 to 4 studies can be accommodated, including Clinical Study Report Synopses for Public Disclosure.

Common Technical Document

Extensive and complete documentation must be presented for a marketing authorization of an investigational medicinal product (IMP) for human use in the European Union, Japan, or the United States. The compilation of these reports forms the basis of the Common Technical Document which has become an internationally agreed format for the preparation of a well-structured presentation for applications to be submitted to regulatory authorities.

We have considerable expertise in the writing and preparation of the Common Technical Document.