Target
- Medical Affairs
- Clinical Development
- R&D
The problem
Manual benefit-risk monitoring can't keep pace with the benefit-risk landscape of standard of care and clinical innovations, creating evidence gaps that directly impact regulatory submissions, DSURs, PSURs, and RMPs.
The solution: the 1st structured Benefit-Risk regulatory-qualified framework
Automated, continuous screening of open-access & closed-sources structured by PICOS framework across all study types.
Early detection of emerging safety signals, efficacy shifts, and population-specific benefit-risk changes, before they reach regulatory scrutiny.
AI-powered extraction of efficacy and safety outcomes, validated against Cochrane, NICE, FDA and EMA evidence synthesis standards.
75% reduction in monitoring time, scalable across portfolios without proportional resource increase.
The impact
Your team delivers systematic, auditable evidence synthesis for regulatory submissions and safety reports, while cutting the competitive intelligence cycle from weeks to days.
"It shortened our competitive intelligence cycle from weeks to days.",
Sanofi Global Head of R&D