Clinical research services
Study planning and design
- Input to protocol (phase II – IIIb)
- Statistical input to protocol (sample size calculation)
- Patient information/consent
- Preparation and submission of documents to ethics committees
- Preparation and submission of documents to regulatory authorities
Study implementations
- Project management
- Monitoring of investigator driven studies
Data management biostatistics
- Database design, data entry, MedDRA-coding, query management (in collaboration with specialised partners)
- Statistical analysis (analysis plan, statistical report, data listings)
Research consulting
- Support in setting up clinical development strategies
Our group of highly motivated and experienced pharmaceutical professionals manages each project and ensures a smooth process that respects timelines and budget.
