Non-commercial study Commercial study

Non-commercial studies Commercial studies Both

Up to 2 users Up to 5 users Up to 20 users > 20 users

Up to 5 users Up to 20 users Up to 50 users > 50 users

Randomisation & Stratification ePro/eCOA/PROMs: survey tool to send questionnaires to patients. Trial Supply Management: Manage the inventory and dispensing of medicines for each participating site. Subject Tracking: Plan and manage visits. Financial management: manage budgets, expenses and fees of participating sites. >50GB data storage None of these functionalities will be used

Digitize the entire process regarding study start-ups. Document Management: sign and store eTMF, Sponsor eTMF & ISF documents. Automatic letter generation. Communication Management: Communicate with all involved roles and participating centers. Financial management: manage budgets, expenses and fees of participating sites. Record all visits and registrations of subjects from all participating centers. Study dashboards & Management dashboards: access to all necessary data for annual reports and inspections. Prepare and manage Smart Safety Reports (SAEs, SUSARs), amendments and progress reports. A digital connection with an affiliated Medical Ethical Review Committee. Capture subject data with Electronic Data Capture (EDC).