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AI-Driven Protocol Digitization for a Global Biopharma
October 17th, 2025 WRITTEN BY Fresh Gravity
Fresh Gravity helped a global biopharma company overcome inefficiencies in manual data mapping by implementing an AI-assisted ML and RAG solution, automating schema-driven data extraction, enhancing scalability, and enabling SMEs to focus on strategic tasks.
Problem
The client faced multiple challenges in managing clinical trial protocols. The lack of protocol digitization impacted development timelines, delaying both study setup and execution. Without capabilities for schema-driven extraction and mapping, standardizing libraries became a cumbersome and inefficient process. In addition, the inability to process protocols effectively led to significant time & cost overheads whenever data model updates were required. Manual mining of old protocols further limited the ability to generate key analytical insights, leaving the organization without the intelligence needed to optimize processes and decision-making.
Solution
Fresh Gravity implemented a comprehensive Azure-based solution for protocol digitization. Data was ingested via ADF and stored in ADLS, supporting batch and real-time sources. Azure Document Intelligence parsed unstructured documents, with Azure AI Search enabling contextual retrieval. A LangGraph agentic workflow, powered by GPT-4o, extracted structured information, mapped attributes to USDM/CDISC, and applied quality checks. A Mendix & FastAPI UI, backed by Azure SQL Database and Azure DevOps CI/CD, streamlined the full user journey with accuracy, governance, and scalability.
