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Optimized Study Design
One team designs protocols that meet EMA and FDA requirements at the same time.
The CRO trusted by teams that can't afford to repeat a pivotal study
Study design optimized for EMA and FDA, with no duplicated effort
Every pivotal study is an opportunity that's hard to repeat. We design protocols that meet both agencies' requirements at once, aligning endpoints, population and statistical plan before the design is locked in.
Endpoint alignment
Statistical plan
Parallel EMA/FDA scientific advice
Pivotal design
Request a meeting
Tell us what stage your protocol is at. We respond within 24-48 business hours.
Response within 24-48h
No obligation
Protocol design in progress
Interactive simulator
👆 Click each milestone to see how we optimize your protocol at that stage
Sample size calculation
Statistical analysis plan (SAP) drafted
Assumptions review with biostatistics
4Protocol design milestones
4EMA/FDA alignment points managed
1Team, entire design
Illustrative example of a dual EMA/FDA study design process
A CRO you can trust
Direct, transparent communication at every design decision, no middlemen.
Budget adapted to your company
Accompaniment plans adjusted to your company's size and stage.
No team handoffs
The same point of contact from the first protocol draft through to its approval.
Continuous follow-up
We don't disappear after the first version — we stay until the protocol is ready to start.
How we work
From the first draft to the final aligned protocol
01
Clinical programme assessment
We review the study objectives and your product's regulatory history.
02
Endpoint and population alignment
We define the efficacy criteria and target population acceptable to both agencies.
03
Parallel scientific advice
We coordinate EMA scientific advice and FDA Type B/C meetings before locking in the design.
04
Final protocol and study start
We incorporate feedback from both agencies and prepare the protocol for study start.
What's included
One single team to design a protocol that works on both sides of the Atlantic
02
Endpoint alignment
We validate efficacy criteria with both agencies before committing to the pivotal design.
03
Statistical analysis plan
We design the SAP and sample size calculation to the rigor each agency requires.
04
EMA / FDA scientific advice
We prepare and accompany parallel meetings with both agencies.
05
Pivotal study design
Phase III protocols designed to serve as the basis for a dual registration.
06
Avoiding duplicated studies
We identify which studies can be avoided thanks to a better-aligned design from the start.
We adapt to you
A plan tailored to your protocol, not a fixed rate for everyone
Design assessment
A first session to review your current protocol and spot points of misalignment between agencies.
Tailored design
We design or adjust your pivotal protocol with a work plan adjusted to your timeline and budget.
Ongoing support
We support you through the protocol's execution, milestone by milestone, through to final analysis.
Why choose Geistek
A misaligned design costs more than budget — it costs time
Friction point
A misaligned design can force you to repeat the pivotal study
Discovering the misalignment after the final analysis is the most expensive way to find out.
Geistek solution
We align endpoints with both agencies before designing
Scientific advice is raised right before the decisions that are hardest to reverse.
Friction point
Each agency interprets evidence differently
A statistical plan designed for only one agency may not convince the other.
Geistek solution
We design a statistical plan valid for both
The SAP is built with both EMA and FDA standards in mind from the first draft.
Friction point
Duplicated studies cost time and budget
Repeating a pivotal study for each agency can add years and millions to the programme.
Geistek solution
We optimize the design to avoid duplication
A well-aligned protocol can serve as the basis for a dual registration.
Our model
A partner integrated into your clinical programme's design
One team, not a one-off delivery
We adjust the design together with your clinical and biostatistics team, not just in the first version of the protocol.
01
Real experience with the EMA and the FDA
Direct knowledge of how to align both agencies' expectations in a single design.
02
Coverage across Spain and the EU
Regulatory management with local presence and the ability to coordinate at a European level.
03
Connected to your regulatory strategy
The study design is coordinated with the rest of your programme, not in isolation.
Coverage across Spain + the European Union
Coordination of the design and regulatory position across different member states when the programme requires it.
Frequently asked questions
Common questions about this accompaniment
What does it mean to optimize a study for the EMA and FDA at once?
It means designing endpoints, population and statistical plan that meet both agencies' evidentiary standards in a single protocol, instead of designing in isolation and risking having to repeat the study for one of them.
Can you adjust a protocol that's already in advanced design?
Yes, we can step in at any stage of the design. The earlier we join, the more room there is to adjust endpoints and statistical plan without rework, but we also review advanced protocols to spot risks before submission.
Do you manage scientific advice meetings with both agencies?
Yes. We prepare briefing books, coordinate the calendar and accompany EMA scientific advice meetings and FDA Type B/C meetings, aiming to align both conversations before locking in the final design.
What happens if the two agencies disagree on something key?
We identify the point of disagreement, assess the impact of each option and help you decide the least costly compromise for your programme, documenting the decision so it's backed in the regulatory file.
Let's start the conversation
Tell us what stage your protocol is at
We'll review your study's context and tell you, with no obligation, how this accompaniment would fit.
Request a meeting
We respond within 24-48 business hours.
Response within 24-48h
Plan adjusted to your protocol
No obligation
