Clinical Studies

Sanipedia offers the following Clinical Trials supporting services:

  • Study Project Management including predisposition of the Trial Master File (TMF), Trial Center File (TCF) and interaction with Local Ethical Committee
  • Predisposition of Clinical Protocol: according to promotor’s indication and notification to Regulatory Institution
  • Development of Case Report Form (CRF) and Databases, using the most adequate instrument according to study type
  • Identification of side effects and predisposition of Safety Reports
  • Study Monitoring and related reports
  • Data Management with quality controls and management
  • Statistical Data Analysis
  • Predisposition of Final Report
  • Predisposition of eventual publications

Main Experiences

Sanipedia’s experiences are focused on the Observational and Interventional Studies ambit, with the peculiar aim of extending indications of drugs/devices already on the market.

  • Observational Studies: particularly in Orthopaedic and Regenerative Medicine areas
  • Health Economics Studies and Heath Technologies Assessment: studies aimed at evaluating comprehensively existing evidences and estimating the cost-effectiveness of different interventions (drugs, devices, ICT systems etc)

More Information?

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