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We deliver state-of-the-art reports compiled by the Assign
cross-functional team.
Internally, we work closely with our physicians and statisticians to ensure
that the document planning and production deliver consistent data interpretation from study initiation through to study finalization.
Our documents are clear and concise, combing language and technical
skills, comprising addenda, in-text tables, figures, charts, graphs,
bookmarks and hyperlinks at highest quality.
Appendices to clinical study reports constitute sometimes the largest components and require extensive management and quality control during report creation and assembly. We ensure that GCP relevant appendices
are ICH E3 compliant and complete. We have profound knowledge of all relevant guidelines.
OUR DELIVERABLES ARE:
– Investigator Brochures
– Investigational Medicinal Product Dossiers
– Clinical Study Protocols for all Phases
– Patient Safety Narratives
– Clinical Summaries and Overviews
– Standard Operating Procedures
OUR 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 Organization of translation
of any non-English documentation, as required Preparation of tables of
contents and cover pages.
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