Greenlight Guru, developer of the Medtech Lifecycle Excellence Platform, has acquired SMART-TRIAL, the maker of the Electronic Data Capture (EDC) platform designed for medical devices and diagnostics. SMART-TRIAL offers a comprehensive data collection toolbox to comply with regulatory requirements on clinical data.

The SMART-TRIAL platform was designed with the purpose of addressing challenges of the medical device and diagnostics industry. This platform is aimed to support an industry with increasingly strict regulations for clinical data collection on medical devices as well as challenges in automating and streamlining the clinical evidence process.

Founded in 2013 by CEO Páll Jóhannesson, CCO Jón Ingi Bergsteinsson, and CTO Alex Bondo Andersen, the SMART-TRIAL has helped over 100 companies collect high quality clinical data in compliance with industry regulations. The SMART-TRIAL platform has evolved into a complete data collection toolbox for Clinical Studies, Clinical Investigations, Clinical Performance Studies, Post-Market Clinical Follow-Up (PMCF), and Post-Market Performance Follow-Up (PMPF).

The acquisition will enable the Greenlight Guru to further expand its platform capabilities and enable medical technology companies to achieve true quality across all phases of the product lifecycle.

“60% of Greenlight Guru clients are currently running a clinical trial or are expecting to run one in the next 2 years, and over half of those are still using paper or Excel to manage the data. That is not only costly but extremely risky given the increasingly strict regulations on clinical data quality,” says Greenlight Guru CEO David DeRam. “Greenlight Guru and SMART-TRIAL have very similar missions and values, and we’re both exclusively focused on providing MedTech companies with tailored software solutions to delightfully meet their needs. I know we can realize our shared goal much faster by combining forces.”

The news follows Greenlight Guru’s recent acquisitions of CanvasGT, a software company enabling iterative MedTech Innovation and the future of the evolutionary design process, and Vertex Intelligence, a data science company developing custom artificial intelligence and machine learning solutions.

“Greenlight Guru’s vision for the future of MedTech is exactly what the industry needs, and we are very happy to be part of what will become the golden standard software platform for MedTech companies around the globe,” says Páll Jóhannesson, CEO of SMART-TRIAL. “With the combined experience of Greenlight Guru and SMART-TRIAL and synergies between the platforms, we will be able to provide an offering for MedTech of unprecedented quality and scale.”

The acquisition and more will be announced at Greenlight Guru’s inaugural True Quality 2022 conference.