Data management
We provide data management process - complex and partial services:
- Creation of documentation (data management plan, data validation plan) and cooperation in the creation of the study protocol
- Ensuring data collection, integrity, completeness and reliability in accordance with FAIR principles
- Design, creation and validation of study database for data collection (eCRF - electronic form)
- Data cleaning, data validation, programming and setting up database controls
- Database locking and data export for statistical processing
Biostatistics
We offer collection, organization, analysis, interpretation and presentation of data obtained from clinical studies - comprehensive and partial services:
- Study design including power analysis (determination of the number of subjects needed)
- Development of the statistical part of the protocol (synopsis) and Statistical Analysis Plan (SAP)
- Development of Interim Analysis and DSMB
- Development of final statistical analysis including report (ICH GCP)
- Preparation of documents for publication of the study results in the professional press
