eTMF solutions & documentation


Artialis will ensure preparation and management of all essential clinical documentation needed to support your clinical trial. It includes :

  • Study synopsis, protocols and protocol amendments

  • Patient information letter and Informed consent form

  • Site logs and forms

  • Subject questionnaires

  • All study plans including Project management plan and associates plans as monitoring, TMF, etc.

  • Study reports and CSR

  • Certified translation of any patient document

Artialis is using trial Interactive eTMF to collect and store documents of your clinical trial. Your trial data will be kept safe in a password-protected environment during your trial.  You will have direct access to any of your trial documents. We will create a TMF plan, and upload and manage documents to ensure consistency, accuracy, and readiness until trial closure and archiving.



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