CTWise.ai is developing AI-powered protocol optimization designed to identify potential issues early, targeting a 40% reduction in costly amendments.[preventable] Percentage of amendments that could be prevented with better initial protocol design Phase-specific costs: $141K (Phase II) to $535K (Phase III) per substantial amendmentFDA Clinical Trials Guidance
2023Tufts Center for the Study of Drug Development
2023
Implementation Time
Fewer Amendments
Saved Per Amendment
76%
Protocol Amendments
Of clinical trials require protocol amendments[amendment], each costing $141K-$535K[tufts] Phase-specific costs: $141K (Phase II) to $535K (Phase III) per substantial amendmentTufts Center for the Study of Drug Development
2023
3-6 months
Implementation Time
Average time to implement an amendment[amendment], affecting time-to-market
45%
Preventable Amendments
Of amendments are potentially avoidable[preventable] Percentage of amendments that could be prevented with better initial protocol designFDA Clinical Trials Guidance
2023
Our proven methodology identifies amendment risks before they impact your trial
Secure, HIPAA-compliant document processing in minutes
500+ regulatory rules evaluated in seconds
Identify violation clusters that predict amendments
Operational metrics that matter, not just compliance
Prioritized recommendations to prevent amendments
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