Study Design / Protocol Development
    Sample Size Calculations
    Adaptive Design Planning
    Sample Size Calculations
    SAP Development
    CSR Development
    NDA/BLA Submission Planning
    Regulatory Interactions & Meeting Representations
    Manuscript / Abstract Development
    Post Submission Support including ADCOM/ODAC
    DMC Management and DMC Charter
  • SDTM
    SDTM CRF Annotation
    Specification & coding
    SDTM data generation
    Pinnacle21 checking
    SDRG preparation
    Define.xml generation
    Issue Tracking
  • ADaM & TFLs
    TLF mock-up development
    Specification & coding
    ADaM data generation & validation
    Pinnacle21 checking
    ADRG preparation
    Define.xml generation
    TLF generation and validation
90+ Projects

ISS/ISE Experience

Validation Keys

Q2BI has independent SDTM/ADaM/TFL validation systems, checking and reviewing including e.g.: mapping, integrity, logic,
compliances, opencdisc, metadata and PPV, to ensure our effective deliverables with excellent quality.

  • Double Programming
    Two independent groups
    Compare until exactly same
  • Communications
    Timely and Effetive
    Quick response
  • Manual Review
    SAP/shell compliance
    Trace back to data
    Output cross-check
    Layout consistence