Medical Writing

  • Protocol

  • Investigator’s Brochure

  • IFU for Medical Devices

  • DSUR

  • Study-specific Documentation

Clinical Operations

  • Site Management

  • Site Monitoring in Sweden, Denmark and Norway

  • SAE/AE Reporting

  • Audit Readiness

  • Recruitment Strategy and Support

  • Review monitoring visit reports

Start-Up Activities

  • CTR and MDR applications

  • Composure and Adaptation of ICF

  • Contract and Budget negotiations

  • Biobank and Local agreements

  • eCRF/eTMF set-up and maintenance

Project Management

  • Manage Client relationship/project team/vendor

  • Lead the day-to-day management of the study

  • Budget and Contract

  • Co-ordinate study planning, timelines, and risk management

  • Track study metrics and status updates

  • Support audit and inspection readiness