Mid-trial amendment packages
More than a redline. We draft the amendment, map every downstream change across sites, IRBs, vendors, and supply, and project-manage the rollout. Industry average from need-identified to last-IRB-approved is 260 days. We compress it.
Every month a trial sits with the wrong protocol costs you patients and money
Tufts CSDD pegs the average substantive protocol amendment at 260 days from need-identified to last-IRB-approved across all sites, with a Phase 3 cost of $535K all-in ($141K for Phase 2). That's a quarter of operating runway for many sponsors. Most of that delay isn't authoring. It's the cascade: site re-training, ICF reconsenting, vendor change orders, IB and CRF updates, supply re-forecasting, country-by-country submissions.
We turn the redline around in 1 to 2 weeks. We project-manage the cascade through to last-site-approved, alongside your clin ops team or in their place.
A complete amendment package, ready for IRB and FDA
Tracked-changes protocol amendment
Clean redline on your existing protocol with every change tracked, plus a final clean version. Reviewer-friendly format.
Justification memo & risk-benefit summary
Section-by-section rationale for every amendment, with risk-benefit framing aligned to FDA expectations.
Updated ICF, IB sections, and CRF deltas
Every downstream document updated in lockstep. ICF rewritten in patient-readable language, IB sections updated, CRF impact mapped.
IRB & FDA submission-ready package
Cover letters, formatted submissions, and submission checklist, ready to drop into your eCTD or sponsor portal.
Most consultants hand you a redline. We map and run the cascade.
A protocol amendment touches sites, vendors, supply, regulatory, and finance. Miss any of them and the rollout stalls. We deliver a single coordinated plan, with named owners and dates, and we project-manage it through to last-site-approved.
- Site re-training plan and materials
- ICF reconsenting strategy for active patients
- Patient-facing communications
- PI and coordinator briefing decks
- IRB submission rollout (central + local)
- Country-by-country amendment plan (ex-US)
- FDA notification and IB updates
- Pharmacovigilance plan deltas
- EDC and CRF reconfiguration
- IRT, central lab, imaging vendor change orders
- CRO statement-of-work amendments
- Drug supply re-forecasting and labeling
- SAP updates and data-handling impact
- Risk-based monitoring plan revisions
- Endpoint adjudication / DSMB charter updates
- Bridging analysis if pre/post amendment data
- Internal alignment: clin ops, medical, regulatory, legal
- Board and investor framing memo
- Site budget renegotiation talking points
- Timeline impact on key milestones
- One-page impact map with owners and dates
- Weekly tracker through last-site-approved
- Embedded PM working alongside your team
- Or full ownership if you don't have clin ops bench
Where sponsors call us
"We're 9 months in and at 23% of target. We need to loosen criteria fast." We benchmark your I/E against successfully-enrolled comparable trials and ship a targeted amendment in 7–10 days.
"DSMB flagged a hepatotoxicity trend." Rush amendment with updated monitoring, dose modifications, and IB language, submission-ready in 5 business days.
"Adding a biomarker arm based on early signal." We restructure endpoints, add the arm, and update statistics, without unblinding or invalidating data.
"Agency asked us to clarify our primary endpoint definition." Targeted amendment with the exact precedent FDA cited. No scope creep.
From need identified to last-site-approved
Drafting in 1 to 2 weeks. Cascade rollout typically 8 to 12 weeks, vs. the 260-day industry baseline.
Diagnose & scope
Same-day kickoff. We pull comparable amendment precedent and scope the change list with you.
Draft package
Tracked-changes protocol, justification memo, ICF, and IB updates drafted as a single coordinated package.
Revise & ship
Two revision cycles, then final submission package in your filing format.
Run the cascade
Embedded PM drives the impact map: site re-training, IRB rollout, vendor change orders, supply, ICF reconsenting. We track to last-site-approved.
Map the cascade, or run it
Pick the on-ramp that fits where you are. Both come with a fixed-fee SOW same day.
Amendment impact map
We map every downstream change a planned amendment would trigger across sites, IRBs, vendors, and supply. No redline.
- One-page impact map across 5 cascade areas
- Estimated rollout timeline by area
- Named-owner template for your team
- 1-hour readout with clinical and regulatory leads
Amendment package + rollout
Drafting, plus an embedded PM who runs the cascade through to last-site-approved.
- Tracked-changes protocol redline
- Justification memo, ICF, IB, CRF deltas
- IRB and FDA submission-ready package
- Embedded PM driving the cascade weekly
Trial in flight, change needed?
Send the change list and current protocol. You'll get a fixed-fee proposal back same day, with a delivery date.