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Clinical Trials Management
Category: 
Other Products & Services
Description: 
  • Study Set-up Activities
    • Feasibility study assessment 
    • Literature review and meta-analysis
    • Clinical Study Design and Protocol Development
    • Statistical planning and sample size estimation
    • IRB regulatory submission, CTA/NDA review
    • Case Report Form development
       
  • Study Conduct Activities
    • Placement of study coordinator (SC)
    • Site Initiation (Site and investigator selection / Site initiation / Site personnel training)
    • 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)
       
  • Study Monitoring
    • Site monitoring visit (Source data verification / Monitoring of patient eligibility and enrolment into the trial)
    • Study Closeout visit
       
  • Post Study Activities
    • Design of the data management plan based on project
    • Data management requirements and SOPs
    • Evaluation of clinical data consistency
    • Site data query
    • Case Report Form data entry, retrieval and management
    • Data security management and document archiving
    • Manuscript / Medical writing