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Research Projects

​Adding value regardless of the product type

Dermocosmetics

Biological samples

Dietary supplements

Medical devices

Design Types

Clinical research with medical devices

Observational studies

Surveys and questionnaires

Ecological studies

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

SCREEN project

National study on innovation in patient screening tests

view more

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