BUSINESS

Clinical Research (CR)

Our support in clinical research studies:
(eg. clinical trials, epidemiological studies, survey studies)

DESIGN

Proposal & Plan
  • Design of study plan
  • Study design consultation
  • Design of allocation plan
  • Sample size estimation
  • Support for protocol development
  • Preparation support for informed consent documents
  • Application support for ethics committees

DATA COLLECTION

Study implementation
  • Study office
    • creating study-related documents
    • convening kick-off meetings and interim review committees etc.
    • support for participating healthcare institutions
      • forming implementation teams
      • arrangement of site initiation meetings
    • responding to inquiries
    • patient enrollment and allocation
    • study progress management
  • Central data monitoring
Data management
  • Data management (DM)
    • design of case report forms (CRFs)
    • creating DM plans (DMPs)
    • data input
    • coding
    • manual check & logical check
    • issuing queries
    • data lock
    • writing DM reports (DMRs)
  • System development
    • electronic data capture (EDC) systems
    • allocation systems
    • other databases

ANALYSIS (Data analysis / Reporting)

Data analysis
  • Design of statistical analysis plan
  • Writing statistical analysis plans (SAPs)
  • Implementation of analysis
  • Creating statistical analysis reports (SARs)
  • Consulting
Reporting
  • Medical writing (manuscript writing assistance)
  • Submission support
  • Point-by-point response letter writing and manuscript revision support
  • Support for conference slide creation
  • Support for conference poster creation
  • Consultation