Exalon supports the PDF publishing of complex documents consisting of different components such as Clinical Study Reports. Depending on the study outline (ideally following the ICH E3 guidance) reports can amount to more than 50.000 pages built from complex main parts and hundreds to thousands of individual tables and listings in the Appendix sections.
At Exalon we have more than 15 years experience in the area of PDF publishing for clinical and nonclinical study reports:
- We help you to create an eCTD ready version of your study report – bookmarked and fully hyperlinked
- Published as single PDF and/or in a granular structure as required for US eCTD submissions (for Study Tagging Files – STFs)
- Customer specific requirements e.g. for footers/headers, pagination will be considered
Leveraging the full power of our in-house developed publishing solution we can adapt the level of automisation individually to each publishing project to ensure very cost-effective and reliable results of superior quality. The semi-automated process allows to update individual parts during the publishing process without losing any previous work which is of unmatched effectiveness.