Sanofi, Flatiron to Collaborate on Clinical Trial Data Acquisition at Point of Care

Pharmaceutical giant Sanofi and health care technology company Flatiron Health, known for its innovative oncology products, on Monday announced a partnership to develop standards for pulling data from electronic health records (EHRs) for use in point-of-care systems in clinical trials.

Since the development of EHR systems, clinicians, researchers and regulators have criticized the hurdles to extracting data in useful formats, for everything from reporting quality metrics to drug development. Of particular concern is the need for electronic data capture (EDC) in clinical trials, to replace the time-consuming, error-prone tasks needed for data transfer at trial sites.

Deyle

Enter the collaboration between Sanofi and Flatiron, which centers on Flatiron’s product, Flatiron Clinical Pipe. Described in a statement as “one of the industry’s first scalable EHR-to-EDC technologies,” it was recently launched in a study by the 2 companies and transferred more than 50% of the study data from the EHR to the EDC.

Time not spent on manual data entry and resolution will allow clinicians at trial sites to spend more time on patient care, and use of an EHR-to-EDC technology could make bringing trials to the community setting less daunting for smaller practices. However, company officials said in the statement that Flatiron Clinical Pipe is equally appropriate for the academic setting.

Having reached the 50% mark in data transfer, the companies said their collaboration will explore additional types of data that can be automatically transferred, allowing trial sites and Sanofi’s investigators to achieve greater levels of efficiency and reduce errors.

Flatiron, already a leading provider of technology for community oncology practices, sees this step as a “natural progression,” Alex Deyle, general manager, Clinical Research, Flatiron Health, said in the statement.

“With the FDA’s guidance on interoperable technology that allows electronic transmission of relevant EHR data to the EDC system, we knew we had an opportunity with Flatiron Clinical Pipe to unlock the potential of data captured in the EHR, reduce the burden of clinical trials and accelerate research timelines,” Deyle said.

Reference

Flatiron Health embarks on strategic collaboration with Sanofi to make clinical trials more efficient by streamlining data acquisition at the point of care. News release. Flatiron Health. May 1, 2023. Accessed May 2, 2023. https://bit.ly/42iKdjy