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Active Protocol

Phase
Patients
Similar Trials
Risk Score
Overall Risk
Based on similar trials analysis
Amendment Risk
Predicted amendments:
Protocol Complexity
Similar Trial Success
Completion rate in similar trials

Critical Warnings

Competitive Landscape

Similar Trials
Competing (Recruiting)
Competition Level

Enrollment Forecast

Target
Est. Duration (Base)
Benchmark

Site Strategy

Recommended Sites
Countries
Pts/Site Target

Additional Recommendations

Protocol Strengths

Detected Therapeutic Area:
Total Matched: Showing:
Mechanism of Action Breakdown

Top Sponsors in Similar Trials

Organizations leading the most similar trials in this therapeutic area

Sponsor analysis based on similar trials not yet available.
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Amendment Risk
Complexity Score
Similar Trial Success
Trials Analyzed

Design vs. Successful Trials

Metric Yours Benchmark

Top Amendment Risk Drivers

Terminated Trials

No terminated trials in similar set - positive indicator

AI-Powered Recommendations

Screen Failure Prediction

Predicted Ratio
Benchmark
Best in Class
Your Exclusions

Your Criteria vs Similar Trials

Criterion Your Value % Similar

Patient Pool Estimation

Global Estimate

Eligibility Optimization Suggestions

Your eligibility criteria are well-aligned with similar trials. No major optimization suggestions.

Your Primary Endpoint

FDA Alignment:

Primary Endpoint Types in Similar Trials

Endpoints from Similar Trials

Enrollment Comparison with Similar Trials

Your Target
Similar Trial Mean
Median
Min
Max

Sample Size Scenarios

Scenario Control Rate Treatment Rate Effect Size N Needed Power

Statistical Assumptions

Alpha (Type I Error)
Statistical Power
Expected Dropout Rate
Analysis Method

Sample Size Insights

Your Target vs. Similar Trials

Recommendation

Interim Analysis

Amendment Risk Score
Predicted Amendments
Industry Benchmark
Trials Analyzed

Risk Factors

Historical Patterns from Similar Trials

Recommended Site Strategy

Recommended Sites
Countries
Pts/Site Target
Benchmark Avg
Activation

Regional Distribution

Top Countries in Similar Trials

Sites with Experience in Similar Trials

Site Selection Recommendations

High-Volume Centers

Prioritize sites with ≥3 similar trials for faster startup

Regional Balance

Match regional distribution to similar trials for regulatory alignment

Backup Strategy

Plan for 10-15% site dropout; pre-qualify backup sites

Competitive Landscape

Avoid sites heavily committed to competing trials

Timeline Projections

Target Enrollment: patients

Base Case Assumptions

Scenario Simulator

Enrollment Bottleneck Analysis

Risk Score

Probability Predictions

Termination Risk
Enrollment Delay (>6mo)
Amendment Required

Key Risk Indicators

Execution Risk
Based on protocol complexity
Competition Level
Recruiting competing trials
Feasibility Score
Likelihood of successful completion

Risk Matrix with Mitigations

Risk Factor Prob Impact Mitigation

Regulatory Risk Assessment