Study Reports
Study Report and publications
ICH Integrated Reports
IDDI works with external consultants in medical writing, each one having its own therapeutic area of expertise.
Clinical data are presented with a statistical analysis and complete appendices in an integrated report, using either your standard template or IDDI's template following ICH guidelines.
At your convenience, final integrated reports are delivered in PDF format or as hard copy.
Manuscripts for Publications
From your raw data, we produce a publishable manuscript that follows "instructions to authors" of the journal you have selected. After submission, we also handle the corrections and the response to the reviewers.
Clinical Summaries
When applying for a product license, we can help you to prepare the clinical parts of the Common Technical Document (CTD) submitted to regulatory authorities in US, Europe, Japan and Canada.