Run Your Clinical Trial in Europe | Geistek Pharmaceuticals
Geistek
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
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

End-to-End Trial Management

One team managing your clinical trial across every European site, from startup to close-out.

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

Geistek clinical operations team
One team, not a distant vendor We work as an extension of your clinical operations team, not a black box overseas.
01

Real EMA Experience

Direct, first-hand knowledge of how the agency evaluates trials and dossiers.

02

Coverage Across the EU

A coordinated network of sites and local teams across multiple European countries.

03

Built for US Sponsors

Communication, reporting, and scheduling designed around how US teams actually work.

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.

Prefer to talk directly? Book 20 minutes with our team, no form required.
Book a Call →

Request a Consultation

We typically respond within 24-48 business hours.

Response within 24-48h No obligation Confidential by default
© Geistek Pharmaceuticals — European Clinical Trial Management for US Sponsors