Data management is a key element of any clinical trial, especially with the new GDPR. Appropriate data management is critical in providing valuable and solid data. We manage data via our subcontracted vendor company.

  • Biostatistics
    • Study design
    • Adaptive design
    • Analysis and endpoint strategies
    • Sample size estimation
    • Planning the statistical part of the Protocol
    • Statistical Analysis Plan
    • Randomization
    • IWRS
    • Statistical analysis and Report
    • Statistical consulting
    • Data mining
  • Data Management
    • Data Management Plan
    • Data Cleaning Plan
    • eCRF/CRF design, database development and validation
    • Data processing (entering – including double data entry, cleaning, transforming)
    • Query management
    • MedDRA coding
    • Legacy data to CDISC SDTM format transformation
    • Archiving