• Data management services

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

More Services

Overall Clinical Trial Management

Medical writing

Study feasibility

Regulatory services

Site & Investigator contract negotiation

Data management