What is Protocol Safe?

Protocol Safe is the pharma sponsor product line for protocol-aware adverse event attribution. An isolated AI environment is deployed inside the pharma sponsor's own cloud infrastructure. A retrieval agent ingests the protocol behind the sponsor's boundary and is queried for the trial drug's expected adverse event profile. Content boundary middleware fail-closes against any response that is not a structured probability score. Only the attribution signal crosses the boundary. The protocol never leaves the sponsor's vault. Self-hosted MedGemma handles attribution reasoning; BAAI/bge-large-en-v1.5 handles embeddings.