The solution enables faster, guideline-compliant protocol creation, boosting researcher productivity and accelerating time-to-market for new therapies.
Meet our client
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Client’s Challenge
The client needed to automate the creation of highly regulated Study Protocols, a process that traditionally takes months of manual drafting. The main challenge was generating accurate, large-scale medical text while ensuring strict compliance with ENCePP and internal regulatory guidelines.
Our Solution
We developed an LLM-powered application that automates guideline-compliant Study Protocol creation, integrating directly with the client’s internal standards. The system combines OpenAI models with RAG from PubMed, Semantic Scholar, ClinicalTrials.gov, and internal databases to ensure accuracy and relevance. Built with Python, FastAPI, PostgreSQL, and S3, the MVP is now ready for testing and accelerates protocol development from months to weeks.
Client’s Benefits
The solution enables faster, guideline-compliant protocol creation, boosting researcher productivity and accelerating time-to-market for new therapies.
