The acquisition expands capabilities of Greenlight Guru’s industry-leading platform to simplify clinical data management for MedTech companies across the globe
INDIANAPOLIS — June 2, 2022 — Greenlight Guru, pioneer of the only dedicated Medtech Lifecycle Excellence Platform, today announced its acquisition of SMART-TRIAL, the maker of the first and only 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.
MedTech clinical operations are different from other life-science industries, and the SMART-TRIAL platform was designed with the sole purpose of addressing the exact challenges of the medical device and diagnostics industry. The platform has been fine-tuned in collaboration with manufacturers over the past 9 years to ensure an ideal out-of-the-box fit with the clinical life-cycle of devices. With increasingly strict regulations for clinical data collection on medical devices as well as challenges in automating and streamlining the clinical evidence process, the need for SMART-TRIAL’s industry-specific solution to reduce the workload and cost of clinical operations has never been greater.
Founded in 2013 by CEO Páll Jóhannesson, CCO Jón Ingi Bergsteinsson, and CTO Alex Bondo Andersen, the Denmark-based software company has helped over 100 companies easily and effectively collect high quality clinical data in compliance with industry regulations. The SMART-TRIAL platform has evolved into a market-leading 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).
With all 3 SMART-TRIAL founders, as well as their team of 20+ employees set to join Greenlight Guru, the acquisition will enable the Indianapolis-based company to further expand their 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,” said 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.”
“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,” said 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 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. The addition of SMART-TRIAL further establishes Greenlight Guru as the definitive leader in MedTech Lifecycle Excellence, a new category of software for medical device companies focused on end-to-end product lifecycle excellence from idea to commercialization to post-market surveillance and beyond. The acquisition and more will be announced at Greenlight Guru’s inaugural True Quality 2022 conference, taking place in San Diego June 6-8, 2022.
About Greenlight Guru
Greenlight Guru is the only dedicated Medtech Lifecycle Excellence Platform designed specifically for medical device companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru’s platform is used by thousands of organizations across the globe to push beyond baseline compliance and achieve True Quality for their medical devices. For more information, visit www.greenlight.guru.