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Clinical Trials
  • Clinical Study Design and Protocol Development
    • Study design for clinical trials, clinical
    • outcome studies, therapeutic equivalence studies
    • Protocol development
    • Statistical planning and sample size estimation
    • Literature review and meta analysis
    • Case Report Form development
  • Clinical Trial Management
    • Site Initiation (Site and investigator selection / Site initiation / Site personnel training)
    • Site monitoring (Source data verification / Monitoring of patient eligibility and enrolment into trial)
    • Project Management (Clinical Research Associate services / Study coordination with study sites, sponsor and study related vendors / Management of deliverables and progress reports / Serious Adverse Events reporting)
  • Clinical Database Design
    • Design of data entry and database applications
    • Data security management and procedures
  • Clinical Data Management
    • Design of the data management plan based on project
    • data management requirements and SOPs
    • Case Report Form data entry
    • Evaluation of clinical data consistency
    • Site data query
    • Case Report Form retrieval and management
    • Document archiving