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Service Areas

Seven service areas covering every stage of a clinical trial.

  1. 01

    Regulatory Affairs / Consulting

    • Regulatory and market access strategies
    • Product registrations
    • Regulatory dossier writing (CTD packaging and CTD writing)
    • Gap analysis
    • Orphan drug designation
    • CE registration (MDR, based on ISO 14155)
  2. 02

    Medical Affairs

    • Synopsis and protocol writing
    • CSR writing
    • Clinical development consulting
    • Medical monitoring for clinical trials
    • Medical consulting
  3. 03

    Clinical Operation

    • Specialized focus on tasks by dividing teams
    • Site and investigator feasibility
    • IRB affairs
    • Study and site monitoring (start-up/PSV, SIV, SMV, COV)
    • Unblinded part operation
    • Risk-based monitoring
  4. 04

    Data Management

    • Data management
    • Design/development of CRFs
    • EDC set-up (Medidata, CRScube, SafeSoft)
    • Medical coding (certified MedDRA coder)
    • SAE reconciliation
    • External data handling
    • Data quality control
    • Data matrix
    • Dedicated DM
    • CDISC (Clinical Data Interchange Standards Consortium)
    • SDTM (Study Data Tabulation Model)
  5. 05

    Biostatistics

    • Statistical consulting and design
    • SAP and SAR writing (Statistical Analysis Plan and Result)
    • Sample size calculation
    • Randomization & IP management
    • Interim and final statistical analysis
    • Additional statistical analysis (TLG generation)
    • CDISC ADaM (Analysis Data Model)
  6. 06

    Quality Assurance

    • Quality management system/consulting
    • GCP/PV audit
    • Project audit
    • GCP SOP development
    • Clinical trial training
  7. 07

    Pharmacovigilance

    • Medical assessment of adverse events
    • Operation and management of DSMB, IDMC and SRC
    • DSUR, PBRER, PSUR, RMP
    • Maintenance of safety databases (ARGUS, cubeSafety)
    • Reporting of ICSR, SUSAR
    • PV SOP development and training