- journal selection
- contact with Editorial Board in order to establish interest in the article
- covering letters
- formatting according to author’s instructions
- response to referees’ comments
- literature searching
Two-phase translations. Each text is additionally reviewed by a selected medical writer specializing in the relevant scientific field.
- Site monitoring and auditing
- Meeting and committee formation
- Regulatory services
- Medical monitoring & safety
Services complaint with ICH and GCP guidelines cover the development of:
- Clinical Study Reports (CSR)
- Electronic Clinical Report Forms (CRF)
- Investigator Brochures (IB)
- Standard Operating Procedures (SOP)
- Statistical Analysis Plans (SAP)
Solutions for the pharmaceutical industry, scientists and other organisations from the biomedical sector.
- Product Monographs
- Patient and physician education materials
- Conference abstracts
- Graphic data presentation
- Poster presentations
- Slide presentations
Our team consists of professional writers, reviewers, and editors of scientific texts (Medical Writers). They have broad experience in writing and editing scientific texts for international, peer-reviewed journals, covering all fields of medicine (including basic science, translational and clinical).
REGULATORY WRITING - NEW COURSE
This two-day training workshop covers the basics of writing documents for regulatory use in the pharmaceutical industry. It has been developed both for dedicated medical writers and for any clinical research professionals...