Clinical Development · Interactive Mock-up

Clinical Trial Protocol Intelligence Agent

Analysis complete Pipeline v0.1-mock-up Powered by Claude
Select protocol scenario:
Protocol synopsis (input)
Amendment Risk Score — composite risk / 100
Predicted Enrollment Delay — vs planned timeline
Projected Screen-Fail Rate — of screened patients
Avoidable Amendment Exposure — estimated cost at risk

Amendment risk drivers

Historical amendment causes

Agent workflow

5 stages
01 Protocol Parsing Extracts structured I/E criteria, endpoints, biomarker requirements, and visit schedules from protocol synopsis into a machine-readable schema.
02 Historical Benchmarking Queries amendment registry (6,400+ protocols) and ClinicalTrials.gov for comparable trial design patterns and amendment frequency by indication and phase.
03 Risk Identification Claude long-context analysis flags eligibility ambiguities, endpoint operationalization gaps, and safety monitoring deficiencies against FDA guidance RAG.
04 Population Modeling Simulates revised eligibility criteria against real-world patient databases (Flatiron, Tempus) to quantify enrollment impact of each criterion change before protocol lock.
05 Site Feasibility Scores investigator sites on biomarker infrastructure, patient volume, prior screen-fail rates, and protocol-specific fit using a composite feasibility score.

Amendment risk register

Risk item Category Likelihood Est. cost Severity

Eligibility criteria optimization

Population impact

Eligible patients from screened population

Enrollment trajectory

Site feasibility ranking

Site Location Enroll / mo Population fit Prior trials Fit score

Comparable trials

Loading from ClinicalTrials.gov…
Fetching live data from ClinicalTrials.gov…

About this agent

01

Protocol Parser

Ingests protocol synopsis, investigational plan, or full ICF. Extracts structured I/E criteria, endpoints, biomarker requirements, and visit schedules into a machine-readable schema.

02

Amendment Intelligence

Queries a registry of 6,400+ historical protocol amendments. Identifies recurring failure patterns by therapeutic area, phase, and endpoint type with root cause analysis and cost attribution.

03

Population Modeler

Simulates revised eligibility criteria against Flatiron Health and Tempus real-world patient databases. Quantifies enrollment impact of each criterion change before protocol lock.

04

Site Feasibility Scorer

Evaluates investigator sites on biomarker testing infrastructure, patient volume, historical screen-fail rates, and protocol-specific therapeutic area expertise using a composite fit score.

05

Regulatory Alignment Check

Cross-references draft protocol against FDA guidance documents, EMA scientific advice letters, and comparable approved-drug labels to flag pre-submission alignment gaps.

Tech stack

Claude (Anthropic) LangChain / LlamaIndex ClinicalTrials.gov API Flatiron Health RWD Tempus Insights CDISC ODM / CDASH CTMS Integration FDA Guidance RAG Veeva Vault API CCAF-certified delivery

Interested in a pilot?

We deploy this agent against your actual protocols with enterprise safeguards, audit trails, and CCAF-certified delivery. Typical engagement: 8–12 weeks from scoping to production.

Start a conversation →
Part of the IT Sunset research-to-clinical pipeline ← Target Identification & Validation Agent
Disclaimer

This dashboard is a concept demonstration developed by software engineers to illustrate how an AI-assisted clinical trial protocol analysis workflow might look in practice. It has not been reviewed, validated, or approved by clinical researchers, regulatory professionals, or biostatisticians. All protocols, risk scores, amendment predictions, enrollment projections, and site rankings are hypothetical and presented for illustrative purposes only. Nothing on this page constitutes clinical development advice, regulatory guidance, or a recommendation for any trial design decision. Any real-world application of AI in clinical trial design must involve qualified domain experts and comply with applicable regulations including ICH E6(R3) GCP guidelines.