End-of-Phase-2 & pivotal design
The most consequential trial of your program. Designed against every approved label in your indication, with three options modeled before you commit.
A pivotal design choice you make in three weeks shapes the next three years
EOP2 is the most consequential regulatory interaction in most programs. The endpoint, comparator, and statistical framework you walk in with sets the bar for approval. Get it wrong and you run a trial that produces ambiguous data, regardless of what it cost.
Most sponsors design pivotals using internal opinion plus a few precedent labels their CRO recalls from memory. We model your design against every approved program in the indication, every CRL, and every advisory committee outcome, quantitatively, with citations.
A defensible pivotal strategy, with the trade-offs quantified
EOP2 briefing book & question list
Full briefing book (typically 80–150 pages) with all Phase 2 data summarized, regulatory framing, and 4–8 questions structured for actionable FDA responses.
Pivotal protocol synopsis with 3 design options
Three candidate designs (typically: superiority, non-inferiority, accelerated approval pathway) with sample size, cost, timeline, and regulatory risk for each.
Endpoint precedent & approval pathway analysis
Every approved label in your indication, with the trial endpoints that supported approval and the pathways used (full, accelerated, breakthrough). Quantitative, not "we recall a couple of programs."
Sample size & timeline scenarios
Power calculations across the design options, enrollment-rate modeling against site capacity in your indication, and total cost projections.
A team most consultancies can't field at this price
Quantitative precedent, not anecdote
Our proprietary platform indexes 100K+ trials, every approval letter, advisory committee transcript, and pivotal trial outcome in your indication. We answer "what has FDA accepted?" with data, not memory.
Regulatory + clinical, in one room
Senior clinical and regulatory specialists co-design the strategy, matched to your indication and Phase 2 dataset. Our in-house team coordinates across both functions and signs off on every output. You don't pay two firms to coordinate through your team.
Three options, not one opinion
We don't fall in love with one design. You see three, with the trade-offs quantified, so the decision belongs to your board, with documented rationale you can revisit at any milestone.
From kickoff to FDA-ready package, 12 to 14 weeks
Phase 2 review & precedent
Deep dive on your Phase 2 data, plus full pull of indication-level approval precedent from the platform.
Design options workshop
Three candidate designs developed with sample size, cost, and risk modeling. Joint sessions with your team.
Briefing book draft
Full EOP2 briefing book drafted, with question framing aligned to your selected design path. In-house clinical and regulatory review.
Mock, sign-off & finalization
Mock EOP2 meeting, revisions, in-house expert sign-off, and final FDA-ready package with all source files.
Validate the direction, or run the full EOP2
Pick the on-ramp that fits the milestone. Both come with a fixed-fee SOW in 24 hours.
Pivotal design memo
A single recommended design with a quantitative precedent landscape, before you commit to the full EOP2 package.
- Recommended design synopsis (10–15 pages)
- Endpoint precedent and approval pathway analysis
- Sample size and rough cost order
- 2-hour design review with your team
Full EOP2 + pivotal package
EOP2 briefing book, three design options, mock meeting, and in-house sign-off.
- EOP2 briefing book and question list
- Three pivotal design options with full trade-off modeling
- Sample size, enrollment, and timeline scenarios
- Mock EOP2 meeting and final FDA-ready package
Approaching pivotal design?
Send your top-line Phase 2 data and target indication. You'll get a fixed-fee proposal within one business day, with timeline, fee, and proposed clinical and regulatory staffing.