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.