The Data Management Unit handles the data processing, employing the world-recognized Clintrial (version 4.4) database designed for clinical trials. The staff has been specially educated in data base management and has additionally completed advancement-training courses. Their focus is on providing high quality data management for a wide scope of trials in different designs, levels of complexity, and required data quantities.
Data Management services include:
- CRF Design
- Database Design
- Data Entry
- Data Validation
- Data Tracking and Reporting
- Medical/Clinical Coding
- Quality Control
Statistical analysis is conducted and data processed by employing the SAS (version 9.1) software package. Our Company statisticians have sufficient experience to handle most statistical requirements in-house. Whenever special needs arise, statisticians from the Kaunas University of Technology and Kaunas University of Medicine are always available to assure all project completions for the Company. Statistical analysis and reporting always completely comply with Statistical Principles for Clinical trials (ICH E9).
Biostatistics Services:
- Study Design
- Sample Size Calculation
- Randomization
- Statistical Analysis Plan Development
- Pharmacokinetic Analysis
- Statistical Programming (SAS software)
- Statistical report writing