Europe is not one clinical-trial “country”. It is a portfolio of ecosystems operating under a shared legal framework, with meaningful differences in speed, feasibility, patient access, cost, and operational friction. For Pharma and Biotech decision makers, the practical question is rarely “Western or Eastern Europe for clinical trials?” but rather:
In this article you will find a structured, data-backed comparison, with a specific focus on what changed after CTR (Regulation (EU) No 536/2014) and the Clinical Trials Information System (CTIS) went live.
Global country utilization has become more concentrated over the last five years.
The analysis of industry-sponsored interventional trials shows that Western Europe’s share of global “country-uses” fell from 32% (2019) to 25% (2023), and Central/Eastern Europe fell from 17% to 11% over the same period.
At the same time, industry voices have been blunt about Europe’s competitiveness: reporting on EFPIA findings, the Financial Times highlighted that Europe’s share of global commercial trials dropped materially over the last decade, alongside concerns about fragmented operations and slower timelines, with Spain called out as an exception due to ecosystem investment and simplification.
So what are the implications for sponsors? Europe is still essential for market access, diversity, and scientific leadership, but country selection inside Europe is becoming more “portfolio science” than tradition. Western and Eastern Europe play different roles in that portfolio.
The key policy milestones included:
What CTR/CTIS actually changes for sponsors:
During the 3-year transition period, sponsors submitted 10,608 initial clinical trial applications in CTIS (including new, transitioned, and resubmitted), and between 31 Jan 2023 and 30 Jan 2025 the system averaged ~200 new initial applications per month.
This means that CTIS is no longer a “pilot reality”. It is the operating system, so Western vs Eastern Europe must be evaluated under the same submission mechanics, but different local execution realities.
From the EU/ACT EU report on the CTR transition period, the total number of CTIS trial submissions involving each Member State in 2024 shows a clear concentration on Spain, France, Germany and Italy.
If we group countries by Western/Nordic/Southern vs Central & Eastern Europe (CEE) (e.g., Poland, Czechia, Hungary, Romania, Bulgaria, Baltics, Slovakia, Slovenia, Croatia), then the regional trend is very clear:
Western Europe still captures the majority of “involvement volume,” but CEE remains a material share and often over-indexes in certain phases/therapeutic areas where recruitment speed is critical.
It is important to understand what CTIS standardizes and what CTIS does not eliminate:
Having this in mind the key takeaway for the Sposors should be that under CTIS, regulatory submission is more uniform, but the “critical path” often shifts to country-specific execution – especially contracting and site activation.
EFPIA’s ecosystem assessment notes substantial variation across EEA countries and explicitly highlights Poland, Spain and Denmark as showing fast recruitment rates (i.e., not purely “East vs West,” but “ecosystem maturity + patient access + execution”).
Why CEE frequently performs well for enrollment in practice (generalizable mechanisms):
But the nuance is important – Western Europe can outperform when you need:
It’s widely accepted in the industry that Western Europe is typically more expensive than CEE on site costs and operational expenses, but published numbers often come from heterogeneous, vendor-specific datasets. For strategic decisions, the bigger concept is:
Probability-adjusted cost = (cost per enrolled patient) × (risk of missing enrollment timelines)
CEE can be cost-advantageous and reduce enrollment risk, which can dominate total program economics (especially Phase II/III). Western Europe may have higher per-patient costs but can significantly reduce risk in:
If you want a defensible, sponsor-grade model, consider building a country scorecard using the following elements:
CTIS reduces the “paperwork penalty” of adding countries from a submission standpoint, which makes portfolio enrollment strategies more attractive: e.g., anchor Western Europe for KOL credibility + diagnostics, and add CEE to stabilize enrollment velocity.
CTIS transparency rules and the public portal mean that more data becomes discoverable by competitors, patients, and investigators over time. Also, Sponsors must be sharper about redaction strategy, document hygiene, and disclosure timelines.
This matters for country choice because some ecosystems are more mature in handling transparency logistics (templates, processes, institutional familiarity), while others may require more sponsor-side operational support.
The EU/ACT EU reporting structure (e.g., submissions by country and year; mono-national vs multinational split) enables better benchmarking and internal learning loops. For example:
Across the transition period, 58% of initial applications were mono-national and 42% multinational.
That split is telling that despite CTIS enabling multi-country, many sponsors still choose mono-national designs, often because operational complexity (contracts, sites, logistics) still dominates over regulatory submission complexity.
Prioritize Western/Southern Europe when you need:
Consider adding CEE (and the Baltics/CEE blend) to the mix when you need:
CTIS makes this architecture easier to operate, but not automatic. You still need country-by-country feasibility with realistic competing-trial assumptions, contracting acceleration tactics (master agreements, standardized budgets, internal playbooks) and an operational owner for CTIS transparency and lifecycle submissions.
In summary, the question of Western versus Eastern Europe for clinical trials has fundamentally shifted from a binary choice to a strategic portfolio decision. The introduction of the Clinical Trials Regulation and CTIS has standardized submission pathways, enforced greater transparency, and improved predictability at the regulatory level, but it has not erased the structural differences that define how trials are actually executed across Europe.
Western European countries continue to anchor scientific credibility, advanced diagnostics, and highly specialized clinical expertise, while Eastern and Central European countries remain critical for enrollment efficiency, operational agility, and timeline resilience. For Pharma and Biotech decision makers, competitive advantage in the post-CTIS era will come not from where trials can be submitted, but from where they can be delivered with the highest probability of success.
Planning clinical trials in Europe? Let’s chat! Contact our business development team and schedule a call to know how APICES CRO handles the acceleration of study timelines and generation of valuable data according to plan.
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