Amendment Module
Protocol changes, fully analyzed.
Understand the complete downstream impact of protocol amendments: budget changes, coverage implications, operational adjustments, and billing modifications - before you sign off.
Amendments are operational landmines
Protocol amendments average 2.3 per Phase III study. Each one triggers a cascade of changes that are difficult to track manually - and mistakes are expensive.
Document Cascade
One protocol change triggers updates across CTA, budget, MCA, consent forms, and operational procedures.
Hidden Cost Impact
Added visits, new procedures, or frequency changes create budget implications that are easy to miss.
Stakeholder Coordination
Finance, regulatory, clinical ops, and site teams all need different views of the same amendment.
Time Pressure
Amendments often come with tight timelines, leaving little room for thorough impact analysis.
of amendments have unidentified cost impacts
typical manual impact assessment time
average unplanned costs per missed impact
How It Works
From protocol comparison to stakeholder-ready deliverables in hours, not weeks.
Version Upload
Upload the original and amended protocol versions. AI extracts all procedure definitions, visit schedules, and requirements.
Diff Analysis
Automated comparison identifies every change: added procedures, modified frequencies, removed items, and schedule shifts.
Impact Assessment
Each change is analyzed for budget impact, coverage implications, CTA requirements, and operational considerations.
Deliverables
Generate stakeholder-specific reports: budget amendments, MCA updates, CTA change orders, and site communication packages.
Generated Deliverables
Budget Amendment
Line-item cost changes with justification
MCA Update Package
Coverage re-analysis for changed procedures
CTA Change Order
Draft amendment to trial agreement
Site Communication
Operational impact summary for sites
Amendment Impact Workbench
Upload two protocol versions and get a complete impact analysis across budget, coverage, and operations.
| Change | Procedure | Visit/Frequency | Impact | Coverage |
|---|---|---|---|---|
| Added | PET/CT Scan | Cycle 4 Day 1 1x | +$3,200 | Sponsor → Sponsor |
| Modified | CBC with Differential | All Cycles Weekly → Twice Weekly | +$12,600 | Medicare → Medicare |
| Added | Cardiac Troponin | Screening, C1D1, EOT 3x | +$255 | N/A → Sponsor |
| Modified | MRI Brain | Screening, C4D1 1x → 2x | +$2,800 | Medicare → Review Needed |
| Removed | Chest X-Ray | Cycle 2 Day 1 1x → 0x | -$250 | Medicare → N/A |
PET/CT Scan
AddedChange Details
Coverage Impact
Notes
New imaging requirement per FDA feedback
Stop flying blind on amendments
See the complete impact of your next protocol amendment before you commit. Request a demo with a real amendment scenario and we'll show you what manual review misses.
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