How does Burna AI help pharma and biotech sponsors?

Burna AI helps sponsors get the label right the first time. At each site, every adverse event is graded on the CTCAE version the protocol names and scored for attribution against every drug in the regimen with the WHO-UMC and Kramer algorithms, with the evidence from the medical record attached and an investigator's signature on the result. In a combination trial, the backbone and the investigational agent are scored separately, which helps elucidate the safety profile while the label is still being written. Sponsors read graded safety data for their own trials in a sponsor view separate from the site view, and compose patient-reported outcome instruments that participants complete in Healthnotes. The platform produces FDA MedWatch, IRB and serious adverse event reports from the signed record. The same engine runs from first-in-human trials through postmarket surveillance. AI suggests, clinicians decide.