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End-to-End Trial Management
One team managing your clinical trial across every European site, from startup to close-out.
European CRO built for US sponsors
Run your clinical trial in Europe, with a team that speaks fluent EMA
A dedicated European CRO for US biotech and pharma companies expanding their clinical development abroad — full-service trial management, site coverage across the EU, and a regulatory pathway aligned with both the EMA and the FDA.
CRO Europe
EMA Regulatory Experience
EU-Wide Site Coverage
Dual EMA/FDA Pathway
Request a Consultation
Tell us where your trial stands. We typically respond within 24-48 business hours.
Response within 24-48h
No obligation
European Site Coverage
Interactive overview
🇪🇸 Headquartered in Spain — coordinating sites across the EU
👆 A few examples below — not the full extent of our network
+ Italy
+ Netherlands
+ Portugal
+ Belgium
+ across the EU
Spain — Coordination Hub
EMARegulatory Base
ESLocal Team
24-48hResponse Time
Our core team operates from Spain, coordinating site activation and regulatory alignment across the countries below.
Spain is our operational hub — shown countries are examples, not the full extent of our EU network
A CRO You Can Trust
Direct, transparent communication at every stage — no black box, no middlemen.
Budget Adapted to Your Trial
Flexible engagement models based on your program's size and stage.
A Plan Built Around Your Program
No generic templates — every engagement is scoped for your specific trial.
Time-Zone-Aware Support
Scheduled calls and updates that fit your team's working hours, not just ours.
How We Work
From your first call to an active site in Europe
01
Initial Assessment Call
We review your protocol, current FDA pathway, and where Europe fits into your plan.
02
Country & Site Selection
We identify the right countries and sites based on your indication and timeline.
03
Regulatory Alignment
We coordinate your EMA pathway alongside your existing FDA strategy.
04
Ongoing Management & Reporting
Monitoring, data management, and clear reporting back to your team in the US.
What's Included
Full clinical trial management, built for a European footprint
02
Site Selection & Feasibility
Country and site selection based on indication fit, recruitment speed, and cost.
03
Clinical Monitoring (CRA)
On-the-ground monitoring visits and protocol compliance across your European sites.
04
TMF & Data Management
Trial Master File organization and clean, traceable clinical data throughout the study.
05
EMA Regulatory Alignment
Your European regulatory pathway coordinated directly with your existing FDA strategy.
06
US-Facing Reporting
Regular updates and a single point of contact your team can reach on your schedule.
Why Sponsors Choose Us
Running a trial abroad shouldn't feel like a leap of faith
Domestic-only development limits your regulatory options
Staying US-only means missing the chance to build EMA data alongside your FDA pathway.
We open the EMA pathway alongside your FDA strategy
Your European data is built to support both regulatory pathways, not just one.
Coordinating with a distant CRO feels risky
Time zones, unclear communication, and a vendor that disappears between milestones.
One dedicated team, clear communication
A single point of contact who knows your trial end to end, on a schedule that works for you.
US patient recruitment is slow and expensive
Competitive trials and rising site costs are stretching timelines and budgets.
European sites, evaluated on merit
We help you assess where recruitment and cost actually work in your favor — country by country.
Our Model
A European partner that fits into your US-based team
One team, not a distant vendor
We work as an extension of your clinical operations team, not a black box overseas.
Real EMA Experience
Direct, first-hand knowledge of how the agency evaluates trials and dossiers.
Coverage Across the EU
A coordinated network of sites and local teams across multiple European countries.
Built for US Sponsors
Communication, reporting, and scheduling designed around how US teams actually work.
Frequently Asked Questions
Common questions from US sponsors
How is running a trial in Europe different from running one in the US?
Approval timelines, informed-consent requirements and site selection processes vary by country, but the biggest change is usually regulatory: in Europe you interact with the EMA and national agencies instead of only the FDA. Coordinating both pathways from the start is what avoids duplicating work later.
Do you help align our EMA pathway with our existing FDA strategy?
Yes. We design the European evidence package so it supports both agencies wherever possible, instead of generating data that only makes sense for one of them.
Which countries do you typically recommend for site selection?
It depends on the indication, the recruitment pace you need and your budget. Spain, Germany, Poland and France are common starting points, but the final selection is based on a feasibility study specific to your protocol, not a fixed list.
How do you handle communication across time zones?
We schedule calls and reporting deliveries at times that work for your US team, not just ours, and keep a single point of contact so information doesn't get lost across the handover.
Let's Start the Conversation
Tell us where your trial stands today
We'll review your protocol and current regulatory strategy, and tell you — with no obligation — how a European site network could fit into your plan.
Request a Consultation
We typically respond within 24-48 business hours.
Response within 24-48h
No obligation
Confidential by default
