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Observational Studies

Speed and simplicity in carrying out your studies

From routine clinical practice
to the generation of knowledge

Speed

1

Simplicity

2

Coverage

3

From Design
to communication

icon Start up / Regulatory
  • Regulatory Strategy
  • Approval procedures with the Competent Authorities
  • Approval procedures with Ethics Committees
  • Identification and selection of sites
  • Methodological advice
  • Documentation: Protocol, Patient Information Sheet / Informed Consent (PIS/IC), Preparation of TMF/ISF
  • Negotiation and signing of contracts
icon Project management
  • Global management and coordination
  • Organisation of research meetings
  • Training of the project team
  • Support for and resolution of incidents
icon Clinical operations and monitoring
  • Management of sites and researchers
  • On-site and/or remote monitoring visits
  • Online patient follow-up
  • Site audits/inspections
  • Preparation of annual monitoring and safety reports (DSURs)
  • Notifications to regulatory bodies
icon Data Science and Biostatistics
  • Data management plan
  • Database generation, validation, and cleansing
  • AEs reconciliation
  • MedDRA coding
  • Sample size calculation
  • Statistical analysis
  • Final statistical report
icon Medical writing
  • Final Clinical Study Report (CSR)
  • Scientific dissemination
  • Protocol drafting
  • Literature review reports
  • Writing of scientific articles
  • Management of publications in national and international journals
  • Writing of expert reports
icon Quality
  • Supplier and site audits
  • Study and documentation audits
  • Support during inspections
  • Risk prevention and management
icon Other
  • Personnel selection
  • PHCP projects
  • Clinical training courses
  • Management of payments to sites and researchers

Success stories

COPPADIS Study

The largest study of Parkinson's disease ever conducted in Spain

View more

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