The consistency, scientific accuracy, and full regulatory compliance of the medical documents we develop is the reason our clients trust us for so many years in medical writing.
Our Medical Department is staffed with physicians experienced in clinical research. Their extensive knowledge and expertise in all major therapeutic areas along with access to the most reliable and updated medical databases and resources enable them to develop medical documents of high scientific level for publication or use in clinical trials.
Our medical writing portfolio includes:
- Clinical Study Protocol writing
- Development of patient material, including Informed Consent Forms
- Case Report Form design
- Preparation of Clinical Study Report (CSR)
- Investigator's Brochures (IB)
- Summary of Product Characteristics (SmPC)
- Patient Information Leaflet (PIL)
- Expert Reports/Clinical Overviews
- Efficacy/Safety Summary Report
- Periodic Benefit Risk Evaluation Report (PBRER)
- Development Safety Update Report (DSUR) and Periodic Safety Update Report (PSUR) preparation
- Training Manuals
- Training Material
- Journal Articles and Supplements
- Reviews/Manuscripts
- Product Monographs
- Poster Presentations
- Conference Reports
- Abstracts
- Translations of Medical Scientific Texts