Phase 1 & Phase 2 protocol drafting
A protocol grounded in what's worked. Endpoints, eligibility, and dose escalation modeled against every comparable program in your indication, not pulled from a 10-year-old template.
Protocols that ignore precedent get rewritten in Year 2
The protocol your CRO drafts is usually a templated document with the indication name swapped in. Endpoints don't match what FDA has accepted in your indication. Eligibility criteria are too restrictive. You'll learn that when enrollment crawls. Dose escalation rules look reasonable until your DSMB has questions.
By the time you discover the issues, you've already spent 18 months and $30M running a study that needs an amendment to be salvageable. We design the protocol to survive contact with reality the first time.
A protocol designed to enroll, generate signal, and survive review
ICH E6-compliant protocol document
Full protocol (60–120 pages) following ICH E6(R3), with all required sections drafted to submission quality.
Endpoint & eligibility benchmarking
A side-by-side comparison of your design vs. every comparable program. Where you converge with precedent, where you diverge, and the rationale for each delta.
Statistical analysis plan outline
SAP shell with sample size justification, primary/secondary analyses, and interim analysis triggers. Hands off cleanly to your biostats team or CRO.
Site & PI shortlist (optional add-on)
Ranked list of 20–40 sites with documented experience in your indication and modality, drawn from the Rightview platform. Includes PI track records.
A protocol drafted with the data, not just the template
Real precedent on every design choice
For each endpoint, eligibility line, and visit-schedule decision, we can show you the comparable programs that used it, and their outcomes. Most CROs argue from intuition.
Operationally feasible from day one
We model your eligibility against site enrollment data before it ships. If only 14% of patients meet criteria, you'll know before the IRB does.
Yours to own. No vendor lock.
The protocol ships as Word source files with full revision history. Take it to whatever CRO or sites you want. No retainer to keep your own document.
From kickoff to final protocol
6 to 8 weeks for Phase 1, 10 to 12 weeks for Phase 2.
Discovery & benchmarking
Kickoff, target product profile review, and full precedent pull from Rightview's database.
Design workshops
Design sprints on endpoints, eligibility, dose-escalation logic, and visit schedule. Joint sessions with your team.
Full protocol drafting
First and second draft of the full protocol, plus SAP outline. Two revision cycles. In-house clinical and regulatory review.
Sign-off & handoff
In-house expert sign-off, source files delivered, optional CRO/site handoff package included.
Pressure-test your draft, or have us draft it
Pick the on-ramp that fits where you are. Both come with a fixed-fee SOW in 24 hours.
Protocol gap analysis
We review your existing draft against indication precedent and tell you what to fix before it goes to FDA.
- Side-by-side benchmarking against comparable programs
- 10–15 page recommendation memo
- Endpoint, eligibility, and operational feasibility flags
- 1-hour readout call
Full protocol drafting
A complete ICH E6-compliant protocol drafted from scratch.
- Full ICH E6(R3) protocol document
- Comparator endpoint and eligibility benchmarking
- Statistical analysis plan outline
- Optional site and PI shortlist add-on
Have a protocol to draft this quarter?
Send your TPP or top-line program summary. You'll get a fixed-fee proposal back within one business day.