Scope of Service

  • General Consulting

    Regulatory Strategy Consulting

    Bridging Study Strategy

    Study Design Consulting

    Product Development Consulting

  • Project Management

    Project Management Plan

    Risk Mitigation Plan

    Budget / Timeline Management Plan

    Vendor Management

    Quality Control (QC)

  • Monitoring

    Pre study Site Visit

    Monitoring (SIV,IMV,COV, Query Resolution etc.)

    Documentation (Collection and Maintenance of TMF / ISF / PF)

    Safety Management

    Site Management

  • DM / STAT / CSR

    Data Management

    Statistical Services

    CRF Development (Paper & e-Contents)

    eCRF(CDASH) Development & EDC Build-up
    (Medidata Rave, Oracle InForm, and Target e*Studio)

  • Medical Writing & Research

    Protocol Development (Korean, English)

    CSR Development (Korean, English)

  • RA / SSU

    Regulatory Affairs (IND)

    Feasibility (Site / Investigator Selection)

    PSSV (Pre-Study Site Visit) : Site Qualification Visit

    IRB Submission

    CTA (Clinical Trial Agreement)

    IP / non IP Import

    GSP (Good Supply Practice) Service

  • PMS / Observational Studies

    Post Marketing Surveillance (PMS)

    Observational / Epidemiological Studies

  • Quality Assurance/Training

    Good Clinical Practice Audit(study and/or system audit)

    Subcontractor/vendor Assessment

    Mock Inspection

    Staff Training

  • Drug Registration Service

    Registration Strategy

    NDA Package Preparation / Submission

    Reimbursement Package / Submission

  • Pharmacovigilance

    Set-up and Management of a PV System

    PSUR / PBRER Development

    RMP Development

    Literature Surveillance

    PV SOP writing

    Safety data management

    Signal detection