Protocol Development
ICH-aligned protocols integrating indication-specific science, statistical design, and regulatory strategy from synopsis to final submission.
Protocols Aligned from the Outset
Science, statistics, and regulatory strategy come together at the synopsis stage.
A clear protocol sets the foundation for the SAP, CSR, and regulatory submission documents. ACRO aligns indication-specific science, statistical design, and regulatory strategy from the first draft.
We develop protocols for practical use, anticipating questions from sites, IRBs, regulators, and reviewers.
Why it matters
The protocol is the reference document for all subsequent work. Unclear estimands, eligibility criteria, or analysis timing can create ambiguity across later documents and lead to regulatory questions months later. The globally adopted ICH E9(R1) requires estimands to be defined at the protocol stage.
What we offer
- Full protocol development for Phase 1 through Phase 4 studies
- Synopsis and concept document development
- Alignment with ICH E6(R3), E8(R1), and E9(R1)
- Protocol support for investigator-initiated trials (IITs)
- Protocol support for advanced regenerative medicine studies
How we work
We begin with the synopsis, establishing the design, endpoints, and statistical framework before developing the full protocol. Estimands are defined at the protocol stage in accordance with ICH E9(R1), so primary and secondary analyses are clear from the outset.
Related services
- Biostatistics — The design framework shapes the protocol structure.
- PK/PD Modeling — Sampling schedules are incorporated into the protocol.
- IND Strategy — Protocols are designed with the intended regulatory pathway in mind.