FULLY INTEGRATED CLINICAL STUDY REPORTS INCLUDE:

Preparation of result-independent parts of the text based on a review of the clinical study protocol,
amendments, case report forms, SAP, investigator‘s brochure, Development of in-text tables and figures based
on statistical (end-of- text) tables, figures and listings in consultation with the sponsor and external experts
as appropriate.

Result-dependent parts of the text (including discussion and conclusions sections) based on statistical
analyses, current regulatory guidance, the sponsor’s strategic documents (e.g. target product profile),
published literature Integration and cross- referencing of report text, in-text tables and figures, end-of text
tables and figures, patient safety narratives, and ready-compiled appendices Integration of any
interim analyses as appropriate.

Quality control of the report: consistency, completeness and correctness of all items, cross-references,
stylistic elements, terminology, abbreviations and nomenclature hyperlinked and bookmarked, translation of
any non-English documentation and as required, preparation of tables of contents and cover pages.