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TrialMind: AI Agents for Clinical Research

From literature review to trial design and data analytics, our AI assistants accelerate every step of clinical research and development. We envision a world where AI seamlessly integrates into every stage of clinical development.

Our Vision

Transforming clinical research through intelligent automation, data integration, and advanced AI capabilities across three integrated layers.

TrialMind Architecture for Clinical Research

Transforming clinical research through intelligent automation, data integration, and advanced AI capabilities

Click on each layer to explore the details

Literature Review Agent

Automated literature search, screening, and synthesis for evidence-based research

Data Science Assistant

Statistical analysis, biomarker discovery, and predictive modeling support

Trial Design Optimizer

Protocol optimization, endpoint selection, and sample size calculation

Trial Monitoring Agent

Real-time trial oversight, risk assessment, and quality monitoring

Regulatory Intelligence Agent

Automated regulatory guidance analysis and submission optimization

Large Language Models (LLMs)

Advanced natural language processing for protocol analysis and medical text understanding

Knowledge Graph Engine

Medical ontologies and relationship mapping for comprehensive data understanding

Predictive Analytics API

Machine learning models for patient outcomes, enrollment forecasting, and risk prediction

Document Parsing Service

Document parsing, information extraction, and figure understanding

Entity Linking & NER

Medical entity recognition and standardization across diverse data sources

Recommendation Engine

Personalized recommendations for protocols, sites, and patient matching

Real-time Processing

Stream processing for continuous monitoring and instant alerts

Privacy-Preserving ML

Federated learning and differential privacy for secure multi-site collaboration

Clinical Trial Databases

EDC systems, CTMS, randomization data, and protocol repositories

Electronic Health Records

Hospital systems, EMR data, clinical notes, and patient histories

Genomic & Biomarker Data

Sequencing data, proteomics, metabolomics, and molecular diagnostics

Regulatory & Safety Data

FDA databases, adverse events, drug labels, and regulatory guidelines

Literature & Publications

PubMed, clinical guidelines, conference abstracts, and medical journals

Digital Health Data

Wearables, mobile apps, patient-reported outcomes, and remote monitoring

Claims & Administrative

Insurance claims, healthcare utilization, and population health databases

External Data Partners

IQVIA, Flatiron, Tempus, and other real-world data providers

Specialized AI Agents for Clinical Research

Comprehensive AI-powered solutions spanning the entire clinical trial lifecycle, from evidence synthesis to outcome prediction.

Agent 1
Literature Review Agent

Evidence Synthesis & Knowledge Mining

Representative Publications

Example Use Cases

  • Biomedical research, systematic literature review, meta-analysis
  • Rapid evidence synthesis for value dossiers and HTA submissions
  • Post-marketing surveillance, safety signal synthesis, and competitor landscape analysis

Key Capabilities

  • Automates systematic literature review and meta-analysis (HTA, HEOR, Medical Affairs)
  • PRISMA-aligned workflow: search, screen, extract, summarize
  • Auto-generates GRADE tables, PICO-aligned summaries, and MoA evidence maps
  • Fine-tuned on > 1.3M trial publications and 800K instruction pairs (LEADS model)
  • 23–27% time savings vs manual screening/extraction
  • Outputs structured datasets for downstream modeling or reports
  • Integrates with internal knowledge bases and external databases (PubMed, CT.gov)
Agent 2
Data Science Agent

RWD Analytics & Feasibility Modeling

Representative Publications

Example Use Cases

  • Rapid trial feasibility assessment using existing patient data
  • Automated generation of statistical analysis plans and visualizations
  • Predictive modeling for trial outcomes and sample size optimization

Key Capabilities

  • Natural-language interface for data science and feasibility analysis
  • Generates R/Python/SAS analysis code with 90% re-use rate and > 20% accuracy lift vs LLM baselines
  • Supports CDISC and OMOP data models with real-time execution sandbox
  • Integrates EHR, claims, registry datasets for HEOR and RWE studies
  • Performs eligibility criteria evaluation, site performance forecasting, and endpoint validation
  • Enables digital-twin simulation and external control arm generation
Agent 3
Trial Design Agent

Protocol & Document Automation

Representative Publications

Example Use Cases

  • End-to-end trial design automation from protocol to regulatory package
  • Site and patient selection recommendations for faster recruitment
  • Real-time eligibility criteria simulation to improve study feasibility

Key Capabilities

  • AI-assisted protocol generation and eligibility criteria optimization
  • Drafts Informed Consent Forms (ICFs) and SAPs with 99% regulatory compliance
  • Predictive trial site selection (FRAMM) for greater diversity and enrollment (+10%)
  • Patient-trial matching (TrialGPT) with > 87% expert-level accuracy and 43% time savings
  • Trial outcome prediction (SPOT, HINT) and digital-twin simulation for sample size reduction (> 20%)
  • Connects seamlessly with existing EDC, CTMS, and regulatory tools (Veeva, Medidata, Argus)
Agent 4
Digital Twin Agent

Simulation, Prognostic Modeling & Biostatistics

Representative Publications

Example Use Cases

  • Prognostic Score Calibration: Estimate individualized baseline risk scores to reduce confounding and improve power
  • Sample Size Optimization: Quantify sample size savings using modeled variance and prognostic adjustments
  • Biostatistical Simulation: Support endpoint sensitivity analysis, stratified modeling, and subgroup identification
  • Digital Twin Augmentation: Create synthetic patient populations to fill gaps in rare diseases or low-enrollment subgroups

Key Capabilities

  • Generates realistic, privacy-preserving synthetic patient trajectories across 10,000+ variables with >90% covariate correlation
  • Performs counterfactual and causal simulations to test "what-if" trial scenarios and treatment strategies
  • Implements digital twin–based prognostic scoring to estimate individualized baseline risk and adjust analyses for heterogeneity
  • Enables sample size estimation and reduction via improved variance modeling and covariate adjustment (20–30% fewer patients required)
  • Augments underrepresented subgroups to improve fairness, statistical power, and reproducibility
  • Integrates seamlessly with biostatistical workflows for endpoint modeling, stratification, and covariate adjustment (supports R, SAS, Python)
Agent 5
Trial Operation Agent

Recruitment, Site Selection, Monitoring & Quality Review

Representative Publications

Example Use Cases

  • Site-ranking optimization balancing performance, diversity, and geography
  • Patient-screening automation to reduce screen-fail rates
  • Ongoing data-monitoring and quality review for regulatory compliance

Key Capabilities

  • Predictive site-selection modeling optimizing for enrollment, diversity, and data quality
  • AI-driven patient-trial matching (TrialGPT) — 87% expert-level accuracy, 43% time savings
  • Automated data-monitoring and query generation for medical and data-management review
  • Detects missing, implausible, or inconsistent data across EDC and EHR sources
Agent 6
Trial Outcome Prediction Agent

Endpoint Forecasting & Early Signal Detection

Representative Publications

Example Use Cases

  • Interim analysis support and adaptive stopping guidance
  • Endpoint prioritization and feasibility scoring during protocol design
  • Portfolio-level risk forecasting for corporate decision-making

Key Capabilities

  • Predicts trial success probabilities and endpoint outcomes using protocol, SAP, and patient-level data
  • Learns temporal and hierarchical dependencies between variables (SPOT/HINT)
  • Supports early signal detection for efficacy or futility across ongoing trials
  • Quantifies uncertainty and confidence intervals for regulatory interpretability
  • Enables cross-study meta-prediction and transfer learning across indications

Ready to Transform Your Clinical Trials?

Discover how our AI agents can revolutionize your clinical research workflow and accelerate your path to market.