TrialSync

Clinical protocol design is an unmonitored $50M+ data-synchronization problem. Qualitative scientific literature is manually translated into text-based protocol prose, which biostatistics teams must interpret into script files. This disconnected process causes silent context decay, unmanaged version divergence, and late-stage regulatory rejection loops right before an FDA Investigational New Drug (IND) submission. Every single day of protocol layout delay compromises $600K to $8M in potential market revenue. TrialSync replaces traditional document-shuffling handoffs with an adversarial, state-driven multi-agent network orchestrated over the Band Protocol. Agents collaborate within a synchronized room environment to continuously cross-verify protocol thresholds against live, authoritative biomedical datasets, compressing design cycles from months to minutes. Unified Orchestration Framework Literature Scout Agent (Gemini 1.5 Pro): Authenticated with real NCBI PubMed API keys to extract structured adverse reactions and safety limits from peer-reviewed literature. Protocol Design Agent: Queries live ClinicalTrials.gov v2 endpoints to map historical execution layouts and inclusion/exclusion variables. Regulatory Reviewer Agent: Cross-references active drafts against official black-box warnings and contraindications pulled from openFDA. Enterprise Infrastructure Adapters Instead of processing raw prose, our backend passes strict, type-safe data schemas: CDISC SDTM Standards Encoder: Converts unstructured clinical variables directly into proper FDA-mandated LBTESTCD data attributes. eCTD Submission Compiler: Groups multi-agent decisions directly into ICH M4 modular blocks ready for automated regulatory filing tools. Tamper-Evident Ledger: Applies a SHA-256 integrity hash across the Band metadata pool to prevent undetected downstream protocol mutations.