- Parexel, a contract research organization, has entered a multi-year partnership with Datavant to connect real-world data across all of its clinical trials.
- Datavant’s technology will become part of the standard flow of data in Parexel studies, which will help with connecting real-world data either during or after clinical trials, the companies said in a Wednesday statement.
- The partnership provides Parexel with information that can be used for evaluating therapies, and also allows the company to pursue collaborations with health-care organizations, data aggregators and analytics companies, according to the statement.
The agreement reflects the growing hunger for real-world data in healthcare. In theory, the data would help drug developers see beyond the information gathered in a clinical trial, giving them access to electronic health records, diagnostics and even information from wearable devices, the companies said.
Datavant touts how it "de-identifies" data, protecting patient privacy while allowing it to be linked up with participants in clinical trials. That gives drug developers a fuller picture of how patients are faring, and better prepares the companies to face the regulatory process, Parexel and Datavant said.
Indeed, the Food and Drug Administration has shown an open mind to real-world data. In April, Pfizer won an expanded approval for a breast cancer treatment for men, relying on electronic health records and post-marketing reports instead of a clinical study.
"Real-world evidence is becoming an essential component to evaluating the safety and effectiveness of drug therapies and ultimately to delivering therapeutic advances," Parexel CEO Jamie MacDonald said in the Oct. 9 statement.
The agreement also reflects the changing demands on CROs. Pharmaceutical companies are looking for services beyond clinical trial operations, with a recent emphasis on data collection and analysis.