English

서비스 항목

인허가 컨설팅부터 임상 운영, 데이터 관리, 통계, 품질보증, 약물감시까지 수행합니다.

  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, Protocol Writing
    • CSR Writing
    • Clinical development consulting
    • Medical monitoring for clinical trial
    • 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)
    • Unblind 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