SMART-TRIAL uplifting study safety reporting for MedTech

New SMART-TRIAL Adverse Event reporting capabilities helps medical device companies comply with international standards and regulations on safety reporting in clinical studies

Aalborg, August 17, 2020 SMART-TRIAL has deployed a new global release of its software to enable MedTech clinical teams to comply with international standards on Adverse Event (AE) Reporting, such as the  ISO14155 and the Medical Device Regulation. This move is the first by any Electronic Data Capture vendor to provide in-built functionality directly tackling  compliance requirements set forth by regulations and international standards. 

“The new Adverse Event module shows our dedication to the medical device industry and enables big and small MedTech companies to comply with the new ISO14155 out of the box”  says Pall Johannesson, CEO. 

The new Adverse Event reporting capabilities will provide MedTech sponsors with the most optimal method to record and report AEs in their Clinical Investigations and PMCF studies As most Electronic Data Capture systems come from the Pharmaceutical industry, they don’t fully meet the needs of MedTech. The process of reporting adverse events for medical devices is unique and requires solutions to support these unique requirements. The new update will give clinical teams the ability to quickly and easily collect the relevant data with a setup that is tailor made to their device, saving valuable time. 

New features include: 

• Ready to use templates, geared toward the ISO 14155:2020, the Medical Device Regulation, the Medical Device Directive and Good Clinical Practice. 

• Form customisation giving users full control of Form setup and design based on their unique study and device requirements. 

• Automatic Reminders for immediate action as warranted by Sponsors but with customisation capabilities. 

• Faster Reporting to National Competent Authorities with Adverse Event specific data exports and tying everything together is the overview for users that eliminates manual progress tracking and status checks.  

“ We firmly believe in creating products for our customers and a big part of this update has been to give back power and control to our users so they can collect data the way they want to. We envision that all medtech clinical teams should be able to collect high quality clinical data and our custom AE module is another step in that direction ” adds Johannesson. 
 

SMART-TRIAL is helping MedTech clinical teams to comply with regulations on clinical evidence, by simplifying the collection and management of data. Tailor-made for MedTech, SMART-TRIAL offers a do-it-yourself Electronic Data Capture for clinical investigations and PMCF activities, including registries and surveys. SMART-TRIAL is built to empower clinical teams to be their best, and in full control of their data, without compromising on features, design, or compliance.