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.
Seller
Keiji AIDiscussions
TrialMind CommunityLanguages Supported
English
Overview by
Brian Dufresne