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Dual-Agency Protocol Design
A single optimized protocol designed to meet EMA and FDA evidentiary expectations from the start.
Study design that works for both agencies, from day one
Optimized study design that avoids duplicating your EMA and FDA evidence
Clinical protocols designed to meet both agencies' evidentiary expectations from the start, so you build the data once instead of running the same study twice.
Dual-Agency Study Design
Fewer Duplicate Studies
EMA + FDA Alignment
Protocol Optimization
Evidence Overlap Simulator
Interactive overview
👆 Click a study component to see how it typically overlaps
Typically shared
Primary endpoint
Well-justified primary endpoints are often acceptable to both agencies when selected with input from both sides early on.
Illustrative patterns we see across projects — not a substitute for a real regulatory review
A CRO You Can Trust
Direct, transparent communication at every stage — no middlemen, no fine print.
Budget Adapted to Your Program
Flexible plans based on your program's size and stage of development.
A Protocol Built Around Your Data
No generic templates — every design is scoped to your indication and evidence.
Real EMA and FDA Experience
Direct knowledge of how both agencies evaluate the same evidence, side by side.
How We Work
From protocol concept to a submission-ready design
01
Protocol Design Assessment
We review your current protocol concept and your regulatory plans in both regions.
02
Endpoint & Evidence Mapping
We map which parts of the evidence package can be shared, and which need to diverge.
03
Optimized Protocol Design
We design the study to satisfy both agencies' expectations without unnecessary duplication.
04
Submission-Ready Package
A protocol and evidence plan ready to support submissions on both sides.
What's Included
Protocol design that treats both agencies as one conversation
02
Endpoint Alignment
Primary and secondary endpoints selected with both agencies' expectations in mind.
03
Statistical Analysis Plan Optimization
Analysis plans designed to hold up under both regulatory frameworks.
04
Comparator & Population Strategy
Comparator selection and population criteria evaluated against both agencies' norms.
05
Regulatory Science Review
A structured review of where EMA and FDA guidance overlaps and where it diverges for your indication.
06
Submission-Ready Documentation
Protocol documentation structured to support both regulatory submissions without rework.
Why Choose Geistek
One study, not two, when it's designed right the first time
Running separate studies for EMA and FDA doubles cost and time
Duplicative studies eat into both budget and timeline, often to satisfy requirements that could have been aligned upfront.
One optimized protocol designed to satisfy both from day one
We design the study once, with both agencies' expectations built in from the start.
Endpoints chosen for one agency get questioned by the other
A design that works well for one regulator can create friction with the other if it wasn't considered upfront.
We align endpoints with both agencies' expectations upfront
Endpoint selection considers both regulatory frameworks from the earliest design conversations.
Divergent requirements get discovered mid-trial, forcing redesign
Finding out about a divergence after enrollment has started is one of the most expensive ways to learn it.
We map divergences before the protocol is finalized, not after
Every point of likely divergence is identified and planned for before the study begins.
Our Model
Study design informed by both sides of the table
01
Real EMA and FDA Experience
Direct knowledge of how both agencies evaluate the same evidence, not a theoretical comparison.
02
Fewer Duplicate Studies
Protocol design that looks for genuine overlap, instead of assuming none exists.
03
Budget Adapted to Your Program
Flexible plans based on your indication, phase, and regulatory strategy.
Let's Start the Conversation
Tell us where your protocol stands today
We'll review your study concept and tell you, with no obligation, where EMA and FDA requirements are likely to overlap or diverge.
Request a Consultation
We typically respond within 24-48 business hours.
Response within 24-48h
No obligation
Confidential by default
