eCOA SERVICES


From trial set up to close out


With a highly flexible range of services, Kayentis provides you with personalized support according to your therapeutic area, study location, your organization, timelines and preferences.
Developing program management solutions, Kayentis offers you the ability to build an efficient management system for multiple studies.

Protocol

  • eCOA Strategy
  • Engineering
  • Scientific support

Set up

  • Project management
    • Dedicated Project Manager to assist your team from set up right through to study completion
    • Escalation process defined and shared at the outset
  • Design & validation
    • Our experts help you design and validate your PRO
    • Collaboration with major translation / validation companies
  • Programming of the portal
    • Programming of edit checks / alerts / scores
    • Definition of rights
  • Data management
    • Definition of DMP, DTS, and all necessary documentation

Site initiation

  • Training
    • Participation in Investigator’s meetings
    • Webex
    • Online videos and site brochures
    • Integrated training system via¬†devices
  • Logistics
    • Proactive site preparation and set up
    • Provision of equipment to the sites
    • Re-supply management

Study management

  • Project management
    • Follow-up of the study
    • Management of updates
    • Fleet device/remote monitoring
    • Risk-based monitoring tools
  • 24/7 multilingual support
    • English, German, Spanish, French, Italian, Japanese as standard languages
    • Over 150 additional languages on demand
  • Data management
    • Full Data Management capacity
    • Query management, reconciliation with CRF data
    • Export to any external system

Close out

  • Data management
  • Legal archiving

Program management

  • Program Director
  • Dedicated team