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🌍 Step 1: Select Country
Choose from 22 countries covering all major regulatory authorities. The tool will auto-populate known regulatory intelligence.
📝 Step 2: Fill Required Fields
Complete all fields marked with * (asterisk). The tool uses this data to calculate your readiness score.
🎯 Step 3: Generate Assessment
Click "Generate Intelligent Assessment" to receive your automated readiness score and actionable recommendations.
📊 Step 4: Review Results
Analyze your score, timeline estimate, and country-specific intelligence to make informed decisions.
🎯 Understanding Your Readiness Score (0-100)
Low risk. Proceed with confidence. Minimal barriers expected.
Medium risk. Plan mitigation strategies for identified barriers.
High risk. Consider alternative countries or extensive planning.
🔢 Scoring Algorithm
The tool starts with a base score of 100 and deducts points based on:
- • Regulatory submission required (-10 points)
- • Ethics review required (-5 points)
- • Contracting not started (-15 points) or in progress (-5 points)
- • Resource shortages present (-20 points)
- • Complex special requirements (-10 points)
- • Severe known barriers (-5 to -20 points based on severity)
Select the country where your study will be launched
Primary regulatory body overseeing clinical trials
Whether your study requires approval submission to national health authority
If ethics review by local or national IRB/EC is mandatory
Status of site contracts and legal agreements
Identify if shortages may impact clinical study setup
Any unique or additional requirements beyond standard submission
Describe roadblocks that may slow study setup in this region