Real-World Evidence Consulting

Do you have a medical device that could benefit the pediatric population? Data that could support its use in pediatrics might be hiding in plain sight. 

With appropriate quality controls and analysis, “real-world data" (RWD) from non-clinical trial sources such as claims databases, electronic health records, patient registries, and connected devices can provide "real world evidence" (RWE), supporting a device's safety and effectiveness for its intended population. Including real-world evidence in your FDA application can help streamline your regulatory pathway and accelerate your timeline to patients. 

The PDC is proud to offer up to 20 hours of free consulting services to companies and innovators looking to use RWE to support pediatric indications for use (IFUs) in their FDA filings. PDC staff will work with you to define your RWE strategy and facilitate interactions with FDA pediatric device officers.

Applicants should be within 1 year of FDA submission, be based in the U.S. or have a U.S. subsidiary, and must have adequate regulatory and biostatistical capabilities to support the submission (i.e., the PDC will not complete your data analyses or regulatory filings for you). Applications will be evaluated on a rolling basis based on the unmet pediatric need, suitability of available data sources, and readiness to interact with the FDA.

If you are interested, please complete the brief webform below.