Featured Product
This Week in Quality Digest Live
Health Care Features
Jennifer Chu
Stamp-sized ultrasound adhesives produce clear images of heart, lungs, and other internal organs
Grant Ramaley
FDA seeks to align Part 820 with ISO 13485:2016; why that may not be enough.
Claudine Mangen
If you have the energy to try and address organizational overwork, start small
Gregory Way
Drug designers are rethinking their response to medications that affect multiple targets
Adam Zewe
Research on machine-learning models that can help doctors consult patient records more easily

More Features

Health Care News
Making the new material freely available to testing laboratories and manufacturers worldwide
Google Docs collaboration, more efficient management of quality deviations
MIT course focuses on the impact of increased longevity on systems and markets
Delivers time, cost, and efficiency savings while streamlining compliance activity
First responders may benefit from NIST contest to reward high-quality incident command dashboards
Enhances clinical data management for medtech companies
Winter 2022 release of Reliance QMS focuses on usability, mobility, and actionable insights
The tabletop diagnostic yields results in an hour and can be programmed to detect variants of the SARS-CoV-2 virus
First Responder UAS Triple Challenge focuses on using optical sensors and data analysis to improve image detection and location

More News

greenlight.guru

Health Care

Greenlight Guru Acquires Electronic Data Capture Solution SMART-TRIAL

Enhances clinical data management for medtech companies

Published: Wednesday, June 22, 2022 - 11:59

(Greenlight Guru: Indianapolis, IN)--Greenlight Guru, pioneer of the Medtech Lifecycle Excellence Platform, has acquired SMART-TRIAL, 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. 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 nine 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 more than 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 three SMART-TRIAL founders and their team of more than 20 employees joining Greenlight Guru, its acquisition will enable the Indianapolis-based company to further expand its platform capabilities and enable medical technology companies to achieve true quality across all phases of the product life cycle.

“60 percent of Greenlight Guru clients are currently running a clinical trial or are expecting to run one in the next two 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.”

“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 SMART-TRIAL CEO Páll Jóhannesson. “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.”

First published June 2, 2022, on the Greenlight Guru blog.

Discuss

About The Author

greenlight.guru’s picture

greenlight.guru

Greenlight Guru is the only quality management software designed specifically for the medical device industry.