MediStat is a company that specializes in biostatistics, operating since 1995.
It provides a wide collection of related support services to clients that conduct and manage biomedical research.
The core services of MediStat are clinical trials data management, biostatistical analysis and
SAS programming, quality assurance inspections, training and writing medical reports.
Our staff has the expertise and dedication to provide you with professional services and a positive out-sourcing experience.
We are committed to excellence and customer satisfaction.
The Data Management and Biostatistics Unit consists of qualified personnel, providing highly accurate
clinical data entry and analysis to support clinical evaluation of results and post-study regulatory submissions.
In the early phase of every project, the unit plans and defines the following procedures and means:
- Database design and set-up
- Review of case report forms
- Data coding using standard or client-specific libraries
- Independent double-key data entry
- Electronic data import
- Coherence checking
- Computerized query system
- Data validation and clean up
- Database quality assurance and locking
- Electronic database transfer to clients
As for data management, a biostatistician is assigned to each project.
His/her responsibilities, in collaboration with a senior biostatistician, are to
assist the sponsor in the following steps:
- Protocol design, sample size estimation, statistical analysis plan
- Development of statistical analysis (SAS)
- Management and validation of statistical analysis
- Tables and graphs generated to be directly integrated in the study report
- Clinical/statistical reports tailored to clients’ templates and specifications, written in accordance with ICH guidelines
- Statistical quality assurance
Performing cost-effectiveness analysis for health technologies according to
clients’ purposes, including sensitivity analysis.