SMART-TRIAL

SMART-TRIAL is an electronic data capture tool made for the medical device and diagnostics sector. Teams set up and run their own studies, including post-market clinical follow-up under the EU MDR and IVDR. The supplier presents it as a more flexible alternative to traditional EDC systems.

What SMART-TRIAL offers

• Do-it-yourself study building — lets clinical teams create case-based data collection forms without outside help.
• PMCF and PMPF — supports post-market clinical and performance follow-up surveys and registries.
• Form reuse and safety forms — offers reusable forms and adverse event forms.
• Multi-site studies — scales studies across sites and phases, with data export for analysis.
• Review tools — helps data managers and monitors verify data and manage queries.

Who it works with

It is aimed at MedTech manufacturers and clinical teams. Quoted users include a product marketing manager, a biostatistician and a principal data manager.

Key facts

• Regulations addressed: EU MDR and IVDR
• Support: training and customer support are offered