SMART-TRIAL Information

SMART-TRIAL is the only Electronic Data Capture solution on the market that is Made for Medical Devices. Developed to improve productivity and reduce the complexity surrounding your clinical operations. It is a single platform for all your clinical data activities, SMART-TRIAL is designed to help you collect and manage data throughout the device lifecycle from clinical studies to post-market surveillance and validation and verification tests. Choose between SMART-TRIAL eCRF, ePRO or combine them in the SMART-TRIAL Suite. The unique SMART-TRIAL study builder, empowers you to set up your study by yourself in just four simple steps giving you control of the entire process. You can quickly design eCRF's from our standard question types that can be customised with automatic rules and validation. With seamless integration to email and SMS, you can collect data directly from subjects and keep them engaged. You can reduce EDC setup time with the ready to use modules like the medication module, AE/SAE and, IoT and API access modules. SMART-TRIAL is trusted by industry-leading Medical Device companies like Oticon, Widex, Ambu, elminda, Bactiguard and more. SMART-TRIAL can help you comply with GCP, CFR 21 Part 11, and HIPAA and has been developed in coherence with IEC 62304 and ISO 13485. We believe that if you have the right tools to manage and collect data, safer and better medical devices will reach healthcare faster. Find out more on www.smart-trial.co See how Oticon is using SMART-TRIAL to perform better and faster tests on their state-of-the-art hearing aids: https://www.youtube.com/watch?v=-I03BZrE_nc SMART-TRIAL is a product by MEDEI ApS