Ritivel

Ritivel revolutionizes the creation of FDA submission documents by transforming raw clinical trial data into compliant reports in mere minutes. Traditionally, medical writers face a lengthy process, dedicating 8 to 12 weeks to manually compile this critical information. Ritivel's innovative system leverages study protocols and statistical outputs to instantly generate these reports, ensuring complete traceability back to the original source data. This addresses a significant bottleneck in pharmaceutical clinical development, where escalating R&D investments have not prevented a 33% increase in trial timelines over the past decade. By accelerating clinical timelines by 20%, Ritivel unlocks substantial revenue potential for each drug by extending patent life. Unlike generic AI solutions that often falter in the pharmaceutical sector due to traceability issues—with only 28% of pilots reaching production—Ritivel's proprietary engine provides word-level traceability, a crucial requirement for FDA compliance. The system links every generated sentence directly to the underlying clinical evidence. Furthermore, Ritivel prioritizes data security by deploying 100% on-premise, ensuring sensitive patient information remains within the client's infrastructure, establishing the company as a trusted AI partner for the pharmaceutical industry. Ritivel automates the most intricate sections of Clinical Study Reports (CSRs), including clinical narratives and biostatistical analysis. The high-quality output, rigorously validated by experienced regulatory writers, is produced at a fraction of the cost of manual writing. Ritivel's team comprises experts from leading organizations like Microsoft, Kearney, and IQVIA, blending advanced AI engineering with deep regulatory expertise to address the critical "last mile" of drug development—a challenge that generic AI solutions cannot overcome due to their lack of understanding of industry standards and FDA requirements.