Services
Medical writing
- Study protocols
- Clinical Study Reports (CSR)
- Investigator Brochures (IBs)
- Lay summaries of clinical trials
- Preparation of clinical dossiers/clinical expert statements
- Responses to questions from authorities
- Publications
- Posters
- Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE)
- Development Safety Update Reports (DSURs)
- Periodic Safety Update Reports (PSUR)
- Risk Management Plans (RMPs)
- Entering study results into EudraCT
- Translation (German and English)
Operational and scientific support for clinical studies
- Study planning
- Medical monitoring
- Literature review
- Medical scientific support during conduct of study
Pharmacovigilance
- Pharmacovigilance support for clinical studies (document and data reviews, pharmacovigilance training)
- Safety signal evaluation
- Safety literature review
- Review of individual case reports
- MedDRA coding
Statistics and statistical programming
- Generally, all study analyses and quality control of study analyses
- Additional/post-hoc analysesinternal resources
- Peer review of third parties’ statistical deliveries (Statistical Analysis Plans; Table Listings Figures TLFs)
- Publications: statistical analyses, tables, graphs
- All services are also available in a package with data analysis and /or medical writing