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CTWise Protocol Analysis Platform

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Preparation Checklist

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Therapeutic Area

Oncology (solid tumors, hematologic)Cardiovascular (MACE, heart failure)CNS/Psychiatry (depression, neurodegenerative)Infectious Disease (bacterial, viral)Rare Diseases

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Study Phase & Design

Phase I (dose escalation, safety)Phase II (proof of concept)Phase III (pivotal, confirmatory)Phase IV (post-marketing)Adaptive/Seamless design

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Regulatory Authorities

FDA (US) - IND requirementsEMA (EU) - CTA requirementsMHRA (UK) - specific considerationsPMDA (Japan) - protocol specificsHealth Canada - CTD requirements

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Current Challenges

Frequent protocol amendmentsEligibility criteria issuesSafety monitoring complexityOperational feasibilityTimeline delays from changes

CTWise.ai

AI-powered clinical trial protocol optimization application that reduces amendment costs by 40% through specialized analysis and 25+ years of biopharma expertise.

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CTWise.ai™ - Protocol Optimization Intelligence