SOPHiA GENETICS Navigates First International Clinical Study with Greenlight Guru

By using Greenlight Guru Clinical and its powerful eCRF capabilities, SOPHiA GENETICS has been able to smoothly manage its first international, multicentric study internally, with thousands of enrolled participants.

SOPHiA GENETICS: Building the Future of AI-assisted medicine

SOPHiA GENETICS is on a mission to advance data-driven medicine and improve health outcomes worldwide. Their goals are to integrate multimodal healthcare-omics data, unlock existing data silos, and develop machine learning models to produce actionable insights that support improved patient outcomes. 

SOPHiA GENETICS is applying its technology to diseases like cancer and inherited disorders, where combining genomic and phenotypic information is vital to support discoveries, treatments decisions, and drug development efforts.

As part of that effort, the company launched the DEEP-Lung-IV study in 2021, an ongoing observational study aimed at unraveling intricate signals linked to treatment responses and prognosis in stage IV non-small cell lung cancer. 

The Challenge: Standardized data collection across 30 study sites

The DEEP-Lung-IV study is the first international multicentric study that SOPHiA GENETICS has run internally. The team needed a system that could securely collect and manage the data from approximately 4,000 patients in eight different countries. However due to the complexity of capturing real-world data (RWD), the company also needed a well-designed eCRF that was flexible and easy for their small team to use. 

After a formal vendor evaluation, one solution stood out: Greenlight Guru Clinical.

The Solution: Greenlight Guru Clinical 

According to Marion Brayer, Senior Director of Clinical Operations, and Barbara Chazot, Senior Clinical Operations Specialist at SOPHiA GENETICS, Greenlight Guru stood out for its balance of flexibility and support. 

“With Greenlight Guru, we have control,” Chazot said. “It’s not like with big providers where you have to formulate your request and give it to a team that has to fit it into their schedule. With Greenlight Guru, we can have the rhythm we need, and the team is really responsive. Furthermore, we feel our comments and feedback are always taken into account which is really appreciated.” 

Flexibility for unique studies

The team also appreciated the flexibility of the eCRF module in Greenlight Guru. The DEEP-Lung-IV study aims to recruit 4,000 patients and must collect their data from within existing medical files. This one-of-a-kind study has very few precedents, so the customizable nature of Greenlight Guru was essential to SOPHiA GENETICS. 

Customizable and compliant

That flexibility doesn’t come at the cost of compliance, however. One of the other reasons SOPHiA GENETICS chose Greenlight Guru was that they wanted strong regulatory compliance built into their solution. Knowing that their data was protected and that there were multiple safeguards in place for privacy and security was critical for them.

“We evaluated five companies and narrowed it down to two. But the other vendor was not formally compliant with ISO 14155:2020. It made a big difference that Greenlight Guru had everything set up for us and ready to use with data protection safeguards and information security,” said Marion Brayer.

Unrivaled support and collaboration

From the very start, the collaboration with Greenlight Guru has made carrying out the DEEP-Lung-IV study easier and helped the team at SOPHiA GENETICS feel more confident in their first internal international study. The team described it as more of a collaborative partnership than a typical vendor-customer relationship.