Protocol Development
Aligned-From-Day-One Protocols
Where science, statistics, and regulation come together at the synopsis stage.
A clear protocol is the foundation for everything that follows — SAP, CSR, regulatory submissions. ACRO drafts protocols where indication-specific science, statistical design, and regulatory strategy are aligned from the first draft.
Protocols built as working documents, not templates — designed to anticipate the questions that will be asked by sites, IRBs, regulators, and reviewers.
Related reading
Why it matters
A protocol is the single document every downstream activity references. When the protocol is ambiguous about the estimand, the eligibility, or the analysis window, that ambiguity propagates into every subsequent deliverable and often surfaces as a regulatory question months later. ICH E9(R1), now globally adopted, requires sponsors to define estimands at the protocol stage — not retroactively.
What we offer
- Full protocol drafting (Phase 1 through Phase 4)
- Synopsis and concept document development
- ICH E6(R3), E8(R1), E9(R1) alignment
- Investigator-initiated trial (IIT) protocol support
- Advanced regenerative medicine protocol support
How we work
Protocols are drafted synopsis-first: design, endpoints, and statistical framework are locked before full expansion. Estimands are constructed at the protocol stage per ICH E9(R1), so primary and secondary analyses are unambiguous from the start.
Related services
- Biostatistics — design framework drives protocol architecture
- PK/PD Modeling — sampling schedule integrated into protocol
- IND Strategy — protocol drafted with target regulatory pathway in mind