Regulatory Medical Writing and Quality Control
I can help you
- During preclinical and clinical development
- from the first draft to the final polishing and everything between (or after, e.g. updates, revisions or amendments)
- All documents follow high professional standards and EMA/FDA and ICH requirements
Flags show the availability for the foreign language
- Topics
- Clinical Studies (all phases and indications)
- Preclinicla studies
- Types of Documents
- Study Reports (CSRs)
- Patient Narratives (fo Safety or Efficacy)
- Informed Consent Forms (ICFs) for different age groups
- Investigator Brochures (IBs)
- Lay Summaries)
- Other study materials ( … more)
- Study Reports (CSRs)
- etc
- This list is not exhaustive and is constantly growing. Please contact me about other types of documents or other services
Service
- Writing
- From first draft to final version
- Version tracking
- Comment-build in
- Tracking of comments from different authors
- Interpretation of data, displaying of data in graphs and tables
- Ensuring consistency with template, style guide, similar documents, etc.
- From first draft to final version
- Quality Control
- Numbers check against source material (Spot checks or 100% verification)
- Consistency with sources and other documents
- Description of results in tables/graphs
- Grammar
- Abbreviations, references, capitalization, hyphenation, footnotes, etc.
- Numbering of paragraphs, tables, illustrations, graphs, etc.
- Formating and hyperlinking
