Our medical writers are experienced scientists and/or native English speakers with proven expertise in timely and accurate preparation in a wide range of therapeutic areas.
We deliver state-of-the-art reports and study protocols compiled by the Assign Group´s cross-functional teams.
Internally, we work closely with our physicians and statisticians to ensure that the document planning and production delivers consistent data interpretation from study initiation through to study finalization. Our documents are clear and concise, combining language and technical skills, comprising addenda, in-text tables, figures, charts, graphs, bookmarks and hyperlinks of the 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 (IB), Investigational Medicinal Product Dossiers, Clinical Study Protocols for all Phases, Patient Safety Narratives, Clinical Summaries and Overviews, Standard Operating Procedures, Clinical Study Reports, including statistical sections, annexes, hyperlinked and bookmarked according to specific guidelines/requirements
Our processes are based on a qualified wide set of : Standard Operating Procedures, Safety Management Plan, Working procedures, Forms and templates
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.