Clinical Research
Our consultants can lead or support clinical research projects across study types and phases:
- Clinical investigation planning and execution
- Clinical trial design (endpoints, methodology, feasibility)
- Protocol development
- Statistical Analysis Plan (SAP) development
- Sample size calculation and power analysis
- CRF design and database specification
- EDC setup and configuration
- Data management and data cleaning
- Statistical programming (SAS, R, Python)
- Interim and final statistical analyses
- Clinical Study Reports (CSR)
- Regulatory submission support (EMA, FDA)
- Post-market clinical follow-up (PMCF) support
In clinical research projects, our consultants:
- have solid experience from MedTech and pharmaceutical studies
- combine statistical expertise with practical study understanding
- prioritize data quality, structure and compliance
- work effectively within small and mid-sized clinical teams
- can take responsibility for defined work packages or full data/statistics scope
- can be engaged short- or long-term, depending on need
- work within the client’s systems and processes
- deliver practical solutions without unnecessary overhead
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