Overview: TrialMind by Keiji AI is an agentic AI platform purpose-built for clinical research. Unlike general-purpose AI tools, TrialMind is a domain-tuned foundation model specifically trained on biomedical and regulatory workflows — supporting every stage of the clinical trial lifecycle, from literature review and trial design through data analysis and regulatory reporting. Backed by 22+ peer-reviewed publications in Nature, NeurIPS, and JAMIA, and deployed in production at organizations like Guardant Health, Regeneron, and Mass General Brigham, TrialMind gives clinical researchers, biostatisticians, and HEOR teams the AI capabilities of a large team without adding headcount. Key Features: Systematic Literature Review (SLR) Agent PRISMA-compliant automation for literature search, screening, and evidence synthesis. Achieves 92–99% screening accuracy and reduces SLR timelines by 50–60% compared to manual methods. Data Science Assistant (DSA) A natural-language copilot for real-world data analytics. Generates SAS, R, and Python code — including SDTM/ADaM programming and TLF outputs — from plain-language prompts. No coding required. Trial Design & Optimization Agent Drafts and optimizes eligibility criteria using historical data from 400,000+ clinical trials. Powered by AutoTrial, Keiji AI's proprietary protocol design model. Digital Twin & Simulation Agent Generates synthetic patient data to simulate trial outcomes and test protocol modifications before execution — reducing costly amendments. Predictive Outcome Modeling (SPOT) Forecasts trial results and risk factors using sequential predictive modeling, helping teams make go/no-go decisions earlier and with greater confidence. Integrations: TrialMind connects securely to external data sources via the Model Context Protocol (MCP), including: PubMed & Embase ClinicalTrials.gov and 13 additional global registries Electronic Health Records (EHRs) Medidata Rave, Veeva Vault, and other EDC/CTMS systems via API Access is available through the Keiji AI platform or via the TrialMind API for embedding into existing workflows. Security & Compliance: SOC 2 Type II Certified ISO 27001 Certified HIPAA Compliant (BAAs in place) Secure-by-Design Architecture: The AI Control Plane operates exclusively on metadata — schemas and variable names. All sensitive clinical, genomic, and regulatory data remains within the customer's secure environment. Raw data never leaves your infrastructure. Full Audit Trail: Every interaction is logged with immutable records, supporting GxP regulatory inspections. ALCOA+ Principles: Attributable, Legible, Contemporaneous, Original, Accurate data integrity standards. Proven Results Oncology RWD feasibility for 20+ data scientists with turnaround times reduce from 6–8 weeks to 3–5 days (10x faster) Protocol authoring & RWD cohort extraction with protocol design time reduced from months to days Large patient dataset analysis Research previously infeasible — now possible Who Uses TrialMind? Heads of Biometrics & Biostatistics HEOR / Real-World Evidence (RWE) Teams Clinical Operations & Trial Design Leads Real-World Data (RWD) Vendors Mid-size and large Pharma/Biotech organizations (Phase 2/3+) Why TrialMind vs. Generic AI Domain-tuned model — Outperforms GPT-4, Claude, and Mistral on clinical trial benchmarks (published in NPJ Digital Medicine) 850K+ trial protocols indexed from 14 global registries; 1.3M+ clinical publications 22+ peer-reviewed publications — not marketing claims Production-proven at Guardant Health, Regeneron, MGB and other leading academic medical centers About Keiji AI Keiji AI was founded with a mission to accelerate clinical trials through AI. The company is led by Jimeng Sun, a professor with 500+ publications, and a team of clinical AI researchers with work published in Nature, Nature BME, Nature Communications, and top AI venues. Keiji AI is headquartered in the United States.