We turn clinical trial data into FDA submission documents in minutes
Ritivel turns raw clinical trial data into FDA submission documents in minutes. Traditionally, medical writers spend 8-12 weeks manually compiling data; our system uses study protocol and statistical outputs to instantly generate these reports with full traceability to the source data.
Clinical development is pharma's biggest bottleneck. Despite rising R&D, trial timelines have increased 33% over the last decade. Accelerating clinical timelines by 20% unlocks hundreds of millions in additional revenue per drug by extending patent life.
Generic AI fails in pharma due to a lack of traceability, with only 28% of pilots reaching production - the FDA requires traceability for all claims. Our proprietary engine solves this with word-level traceability, linking every generated sentence to clinical evidence. We deploy 100% on-premise to keep sensitive patient data within the client's infrastructure, making us a trusted AI partner for pharma.
We automate the most complex parts of CSRs (clinical narratives and biostatistical analysis). Our high-quality output, validated by senior regulatory writers, costs 1/100th of human writing. We're built by experts from Microsoft, Kearney, and IQVIA - combining deep AI engineering with regulatory expertise to solve the "last mile" of drug development—a problem generic AI wrappers can't solve because they don't understand the standards or FDA requirements.