Data Management & Stat
MCT offers appropriate, validated and documented services in data management and biostatistics mainly on non interventional clinical studies or regional phases IV studies. EDC tools can be provided for these projects.
Data manager and statistician are involved from the start of the project and customize database to project specificities and source data for achieving the study objectives.
Our experienced data management staff can provide:
- Protocol review
- CRF design
- Database / eCRF preparation
- Data entry (single or double entry)
- Data review / Query management
- Medical review
- Coding (MedDRA/ WHO)
- Custom reports
- SAE reconciliation
- Export of entered and analyzed data (SAS, Excel formats,…)
Statisticians can provide:
- Protocol review
- Sample size / power calculations
- Statistical Analysis Plan creation / review
- SAS programming
- Tables, figures and listings
- Statistical analysis
- CSR
- Archiving
