Executive summary

  1. Many in the clinical trials industry believe that running a clinical trial in Europe is too expensive, complex, and slow —but the reality tells a different story. With the right approach, adding Europe to your global phase 2 or phase 3 study can offer significant advantages: improved speed, lower costs, and increased global reputation
  2. Europe offers access to a larger, unsaturated, and diverse patient populations, highly experienced sites, efficient approvals processes, and harmonized regulations
  3. Sponsors must still navigate Europe’s diverse regulatory and healthcare environments, despite the unified CTR framework
  4. Strategic planning begins with identifying target high-recruiting and cost-efficient countries, understanding local languages and culture, and tailoring trial designs to meet local needs
  5. Effective execution means handling regulatory, operational, and logistic challenges, building KOL/PI relationships, and ensuring GDPR compliance
  6. Partnering with a CRO with local expertise, strong operational presence and capability, and a wide-ranging site network is crucial for success

Introduction

The US has long been recognized as a global leader in clinical research, with world-renowned sites contributing to a high volume of trials [1, 2]. However, trials are heavily concentrated in main population areas, limiting the number and diversity of available patients, which is now a requirement by the FDA [3]. While US trial sites are excellent, they face challenges such as saturation (of patients and PIs), high costs, finite patient pools, and an unpredictable regulatory landscape. High costs are another factor – according to one source, the estimated average cost per patient in the US is estimated between $36,500 and $41,000 dollars; whereas in Europe this can range from $15,000 to $25,000 [4]. These challenges highlight the need to explore patient enrollment alternatives outside the US.

This white paper, part of a larger series on international clinical operations, highlights key operational considerations and solutions for conducting clinical trials in Europe.

The EMA’s website is primarily useful for information, rather than operational guidance [5]. Only a CRO with specific experience running clinical trials in Europe can provide the latter.

Read on for essential guidance on running clinical trials in Europe.

Note: Europe is a continent of about 55 countries/territories (Figure 1). The EU is a union of 27 European states. This guide covers all of Europe.

Figure 1. Map of Europe. In blue are countries recognized to be in Western Europe, in green are countries recognized to be in Central and Eastern Europe, in dark purple are countries recognized to be in Northern Europe, and in pink are countries recognized to be in Southern Europe, according to EuroVoc. Note that the distinction between Eastern Europe and Southern Europe varies depending on the criteria used. Bold denotes the "big five": France, Germany, Italy, Spain and the UK. European microstates are not shown.

Part 1. Strategic planning

How to prepare for success

The European clinical trials market is projected to grow from nearly $24 billion in 2025 to $43 billion in 2034. However, Europe’s share of commercial trial enrollment declined from 22% in 2013 to 12% in 2023, despite global trial growth [6]. As the US and other become saturated, using Europe’s experience and potential is vital for future clinical trials.

Where to begin?

Choosing priority markets

Which European countries should be our priority markets, and why?

  • Each European country, although under the EU CTIS/CTR framework [7], has different pricing systems, reimbursement policies, and regulations
  • Europe is divided into two main groups: large countries, known as the “Big 5” (France, Germany, Italy, Spain, and the UK), and smaller ones, including the Nordic countries, Benelux, and Central and Eastern European countries (CEE)
    • The Big 5 have more patient populations, strong clinical infrastructure, and drive pricing and reimbursement, but may involve more bureaucracy and logistical hurdles
    • Smaller countries have fewer patients and uneven infrastructure — a challenge in the CEE region without proper planning
      • However, they can offer faster approvals or early access

What are the differences among European countries in terms of healthcare systems, drug pricing mechanisms, and market access strategies?

  • Among the Big 5:
    • France’s single-payer public insurance system provides citizens with accessible, quality care
    • Germany’s multipayer system combines statutory health funds and private insurance, also offering high-quality care
    • Italy’s National Health Service (SSN) is a regional, tax-funded system with some copayments. Care levels vary by region
    • Spain’s Sistema Nacional de Salud is regionally managed and tax-funded, with some copayments. Healthcare experiences can vary
    • The UK’s National Health Service (NHS) is a tax-funded, needs-based system governed by research principles, offering high-quality care
  • Each Benelux country’s universal healthcare system differs — the Netherlands requires private insurance, Belgium combines social contributions with mandatory funds, and Luxembourg has a single-payer fund
  • Nordic countries generally use tax-funded, universal healthcare systems
  • CEE countries aim for universal coverage through mandatory insurance, funded by taxes or competition, but out-of-pocket costs and reimbursement rates vary significantly
  • Reference pricing is common; one country’s price can impact others, especially those in the same region. Access may be delayed in Southern and Eastern Europe due to tough negotiations. Some countries (Germany, the UK) start with free pricing, but later conduct stricter value assessments for payers
  • Across Europe, Health Technology Assessment (HTA) is vital. Real-world evidence, direct comparisons, and cost-effectiveness often matter more for market access than primary endpoints

What advantages or unique value does Europe offer compared to the Asia-Pacific or North American markets?

  • Scientific credibility and reputation: A successful European launch will provide global validation and recognition. It is perceived with the same credibility as a launch in the US
  • Regulatory alignment: Approval by the EMA (over the FDA) can facilitate faster acceptance and approval by other regions (LatAm, the Middle East, and some parts of Asia)
  • Clinical trial expertise: Europe has diverse patient populations, strong and ancient academic institutions, world-leading PIs and KOLs, and robust trial networks in all therapeutic areas
  • Commercial diversification: Adding Europe reduces reliance on saturated US and competitive APAC markets
  • Partnership opportunities: Biotech hubs, especially in Western Europe, welcome collaborations and licensing deals
  • Stability: Investment is generally welcomed in Europe, and the different member states provide a notion of stability where a single decision-maker does not exist
  • Cost: Compared to running a clinical trial in the US, trials in Western Europe (WEE) and Central and Eastern Europe (CEE) are approximately 20% and 28% more cost effective (Figure 2) – these proportionate differences are relatively stable regardless of indication, number of patients, number of sites, or timeline
  • Furthermore, when compared with the US and some parts of Asia, Europe is more competitive in investigator grants (a variety of awards exist, offering up to €6 million from the EU in Europe [8], versus up to $750,000 from the NIH in the US [9]) and CRO fees

Cost comparison

Figure 2. Comparison of the cost of running a full-service clinical trial in the US/Canada, WE, and CEE.
Costs calculated based on a sample oncology trial of 100 participants, and include pass-through costs. Proportionate differences between running clinical trials in the US/Canada, WE, and CEE remain stable regardless of indication, number of patients, number of sites, or timelines.

Choosing the type of trial to conduct

  • Should companies conduct phase 1 trials in Europe, or can they directly enter phase 2/3 trials?
    • First, it is advisable to design pivotal phase 2/3 trials with multinational enrollment in mind. This approach avoids duplicating trials per region, provides a diverse patient population for global regulatory agency submissions, and can strategically result in cost savings, depending on the region(s) where enrollment takes place. Acquire EMA (and FDA) advice where possible, and early
    • Repeating a phase 1 trial in Europe is mostly not required, provided the data is appropriate (i.e., robust data generated under ICH GCP)
    • However, bridging studies may be required in certain situations:
      • If ethnic differences and differences in PK/PD response are not addressed; for example, drug metabolism is notably different between Asian and non-Asian participants, so if non-Asian participants are not well-represented in the phase 1, regulators may perceive the toxicity data as lacking relevance
      • If there is a difference in formulation, dosing, or route of administration between the phase 1 and phase 2/3 trials
      • If data quality, ICH GCP, ethics, or validation methodology are likely to be queried by local regulators
  • Is it possible to support registration through bridging studies or data from other regions?
    • Bridging strategies are well-recognized and governed through ICH guidelines
    • Clinical data can be accepted with a bridging strategy if the study design, endpoints, and data quality of the phase 1 trial are consistent with ICH standards, and the target patient population is either well-represented or shows comparable PK/PD
    • Bridging study options in Europe include a small PK/PD study, to demonstrate no major ethnic differences, or a supportive phase 2 trial to demonstrate dose/exposure/response
    • Generally: Leverage existing phase 1 data, adding bridging trials only if regulators request this data

Part 2. Execution

Transforming projections into achievable milestones

Regulatory complexity

The EMA provides coordination helping to manage this complex process, where individual countries often retain significant autonomy in CTAs, ethical approvals, and drug registration.

What is the current implementation status of the EU Clinical Trials Regulation (CTR) [7]? Has it been fully rolled out?

  • Yes – the EU CTR is now fully operational. CTIS has been live since 31 January 2022, with the transition in effect until January 2025 [10]. Compliance with the CTIS legal framework and the single submission platform for European trials is mandatory. A single CTIS dossier is submitted, covering multiple member states. We advise you to register with CTIS (both sponsor and users) early, and your CRO can assist with this process

Are CTA processes standardized across countries? Are there differences in approval timelines?

  • The CTR harmonizes many elements (submission format [validation and assessment steps], workflow, required content, transparency rules)
  • However, each individual country is responsible for certain national-level aspects (not limited to scientific or ethical assessment, insurance obligations, local labelling, and resourcing). Approval timelines and operational steps will therefore vary by country, as there are practical differences in how RFIs may be handled, when ethical committees meet, the need for translations and local KOL/PI conversations, and how country regulators process contracts and/or insurance
  • The CTIS provides a sponsor handbook and national guidance for timelines, as outlined in the explicit procedures within the CTR (validation and assessment). So, while the CTIS simplifies and harmonizes the process, country-specific operational steps are required and need to be factored into timelines and budget, with contingency time recommended

Should we seek scientific advice from the EMA? Is it advisable to seek simultaneous advice from multiple national authorities?

  • There are different types of scientific advice that can be requested and received, and there are different practical considerations to take into account
  • For pivotal phase 2/3 trials, designed to support EU (and potentially global) marketing, EMA Scientific Advice (CHMP/SAWP) is recommended. This gives pan-EU scientific and regulatory input. National Competent Authorities (NCAs) are brought together to discuss overall development, pivotal study endpoints, and the novelty of the intervention
  • We advise that, if planning to enroll in specific EU countries with unusual national requirements (most often study-specific), you consider parallel Simultaneous National Scientific Advice (SNSA) for consistent input from several NCAs

Are our products eligible for PRIME or ATMP designation? Do they qualify for orphan drug or breakthrough therapy status at the EMA?

  • PRIME (Priority Medicines) is EMA’s early support for drugs that address unmet needs [11]. PRIME provides enhanced scientific interaction and can accelerate development and assessment pathways; however, eligibility is highly selective. Compelling biological, pre-clinical, and phase 1 data are often required; the bar is high, and a minority of applications are accepted
  • Advanced Therapy Medicinal Products (ATMPs), such as gene/cell therapies, follow distinct regulatory pathways [12]. The EMA offers dedicated guidance and liaises with the Committee for Advanced Therapies (CAT)
  • An orphan designation can be available for therapies for rare diseases. Additional incentives – protocol assistance, fee reductions, market exclusivity (10 years at market access level in the EU) – are offered; orphan designation should be applied for in early developmental stages

How do such designations help with future registration and market access?

  • PRIME and ATMP can strengthen a global dossier; frequent and intensive discussions with regulators can lower overall regulatory risk and accelerate development. However, PRIME and ATMP designations do not necessarily align with FDA labels. Parallel discussions with the FDA and HTA should help align expectations for pivotal endpoints. Concerning HTA, the EMA has converging processes that can be used

Operating in a multinational, multilingual environment

Conducting clinical trials in Europe means taking local regulations, culture, and operational models into account. Europe-based CROs have the experience and infrastructure needed to navigate this environment. Working with a CRO experienced in Europe also confers protection against delays, regulatory or compliance hitches, and can protect (and enhance) your reputation.

The multilingual and multicultural coordination requirements include:

  • Standardizing data collection across multiple countries requires adherence to local compliance guidelines and EU-wide GDPR
  • Informed consent forms need to be adapted and translated to multiple languages; cultural nuances and patient population needs should be adequately addressed and controlled for
  • Beyond analysis of biological samples in the local setting, if samples have to be taken for analysis, coordination (transport, storage, tracking) of biological samples across borders is regulated

How should we select countries and sites for our study?

  • More than 3,700 clinical trials were authorized in 2020 across the EU, with each involving an average of two countries [13]. Most countries across Europe therefore have established trial infrastructure – including hospital networks and centralized electronic medical records (for potential patient identification)
  • It is important to balance the geography as best as possible when selecting sites/countries in Europe. Diversifying is a form of risk protection: Each country has its own, unique political and economic atmosphere, and relying on one country too much could result in trial failure if that country experiences any problems
  • Some PIs and sites have prior experience working with pharmaceutical companies expanding from other markets, particularly in oncology and rare diseases. Actively choosing these centers to work with can help reduce the “learning curve” for both the sponsor and the site
  • Choosing countries with noted regulatory and ethical committee efficiency (the Netherlands, Belgium) can help expedite timelines

What is the patient recruitment speed in Europe? Is it more efficient than in the US?

  • While the US benefits from a single language and unified regulatory network, competition for patients is high, and centers are often saturated, massively impacting recruitment speeds
  • Recruitment practices in Europe vary from country to country. You are dependent on a competent CRO with a wide network, who will facilitate country selection and efficient enrollment
  • Median enrollment rate in Europe is approximately 20% faster than in the US or China (Table 1)

Table 1. Comparison of enrollment rate and enrollment duration across different geographical regions. 

Region

Number of trials

# of sites

Enrollment rate (pts/s/m)

Enrollment duration (months)

Median

Mean

Median

Mean

US 

3987

11326

0.81

7.38

10.19

13.49

Europe

2494

8840

0.96

15.68

11.18

14.25

Latin America

250

671

5.46

33.35

8.02

10.85

China

5135

2714

0.81

44.94

12.85

15.12

China + Asia

8676

9462

0.89

35.42

11.7

14.67

Data generated from Citeline November 2025; no indication constraints, limited to phase 2, 2/3, and 3 industry-sponsored trials from 01 January 2015.

Are there significant differences between regions, such as Eastern vs. Western Europe?

  • Countries in Eastern Europe can often recruit faster due to limited access to high-cost medications, making participation in clinical trials an attractive option. Sites and patients tend to be highly motivated
  • Similarly, in Western Europe, patient identification can be rapid due to large, centralized electronic medical records systems; however, patients have broader treatment options, and competition for patients is significantly higher

The EMA has a track record of 30 years of promoting research and innovation [14] – processes are well-rehearsed, and infrastructure and training are in place, and can be supplemented with the expertise of your CRO, and some practical recommendations.

How can we practically manage language and cultural differences across European countries?

  • A local project management team is crucial – understanding the country landscape and cultural nuances is highly beneficial. Multilingual team members can also reduce inefficiencies in communication and harmonization
  • Professional translation services for all patient-facing and PI-facing materials retain the nuances necessary to ensure the material is understood in the intended way
  • Likewise, adaptation of materials for country literacy levels and healthcare norms helps overcome any communication barriers, coupled with adaptations for local cultural norms to appeal to patient expectations
  • Partnering with the right CRO will help build the needed relationships between the sponsor and investigators, whilst ensuring patients receive everything they need to enroll. Nuanced cultural and language factors are not insurmountable, and for an experienced CRO, are an everyday occurrence

Internal organizational and experience gaps

Most companies based outside of Europe lack established clinical operations teams, PI networks, and CRO partnerships in the region, leading to inefficiencies and high communication costs.

  • Should we hire local medical advisors, regulatory experts, or key opinion leaders (KOLs) to support our efforts?
    • Each role adds unique values and perspectives to help make the clinical trial a reality:
      • Medical advisors provide local insights, helping to problem-solve regional medical practice and study design, and are the key point of contact with investigators. Well-established CROs offer Scientific Advisory Boards, an independent group of expert physicians and KOLs for protocol review and operational insights
      • KOLs are incredibly important – their support can make or break your trial. They strengthen credibility with the investigators, can use their referral networks to facilitate recruitment (vital in rare disease indications), and their voice at local/global congresses in support can help enhance visibility
      • Regulatory experts can help navigate the regulations (EU-wide and country-specific), prepare submissions, and anticipate approval timelines

What are the key criteria for selecting a CRO partner in Europe?

  • Many qualities make up the ideal CRO partner – depending on your experience and the trial needs, some are more desirable than others. Many criteria are not dissimilar to those you would look for locally, just with a different geographic application
    • Geographic coverage: Well-established operational presence in all European countries
    • Therapeutic area expertise: A proven and consistent track record of delivering clinical trials within Europe
    • Cultural fluency: Local project teams (monitors, regulatory experts, lawyers, and translators), multilingual project management, and country experts can bridge any communication gaps
    • Regulatory knowledge: Experience with CTR and GDPR, across Europe and within individual target countries
    • Prior experience with global sponsors: Knowledge and understanding of communication styles, decision-making processes, and expectations

Are there any government grants, tax incentives, or innovation funds available for sponsors entering the European market?

  • Financial incentives are available for clinical research and innovation; while there are many rules, restrictions, and compliance requirements to run a clinical trial in Europe, it is an overall welcoming environment
  • EU funding programs, national- or regional-level incentives, disease-specific funds, and partnerships with public research institutions or hospitals can help reach otherwise unreachable potential patients
  • Working with the right CRO can unlock these opportunities – their experience in identifying the right combination of additional funding opportunities can pay dividends further down the development timeline

Supply chain and drug logistics

The safe, compliant, and uninterrupted transport of therapies, also known as investigational medicinal products (IMPs) in documentation, to and within Europe requires navigating GMP, GDP, and customs requirements. As these vary country-to-country (some standardization exists across EU members), this is an absolutely critical factor in successfully executing a clinical trial in Europe.

How can we transport our investigational drugs to Europe? What standards and requirements must be met?

  • Most countries in Europe require import authorization for IMPs manufactured outside Europe. Documentation must be prepared in advance of import, and needs to be aligned to EU CTR requirements and individual national legislation
  • Non-EU shipments must comply with European customs regulations
  • A qualified person (QP) needs to release the imported drugs before they can be used at clinical sites. The QP ensures the product meets GMP standards, and this is a mandatory step that requires local or batch testing
  • Sponsors must consider the impact that cold chain management may have – specialized packaging and validated couriers are required to maintain the drug’s integrity (crucial for many modern therapies, such as biologics)

At what stage of trial initiation should drug logistics and transportation preparation begin?

  • Begin preparing drug logistics and transportation protocols and documentation during the protocol design and country selection phase [15]
    • Protocol development: Define IMP requirements, packaging, and distribution strategy (centralized vs. regional)
    • Regulatory submission: Begin import license and QP certification as soon as trial sites are identified
    • Site initiation planning: Ensure product will be available before FPI
    • Risk management: Include contingency planning for delays (manufacturing issues, customs clearance, or shipping disruption)
  • Starting this process early and being on top of it at every stage can help mitigate potential risks of supply shortages, protocol deviations, and patient safety risks, and can guard against changing geopolitical situations or weather challenges

How should logistics vendors be managed to ensure timely and compliant delivery to study sites?

  • It is crucial to select a CRO with a proven track record of managing multiple vendors across Europe. Well-established CROs have specialized teams that can take care of supply management and ensure a smooth logistical presence. Most CROs have preferred provider partnerships, which are long-standing relationships with key vendors that can be activated as needed. Clearly defining the roles the CRO has helps keep responsibilities clear and avoids gaps and duplicative efforts. The CRO can take care of:
    • Vendor qualification: Selecting those with proven GDP compliance, experience, and quality management systems that match the trial’s needs
    • Performance oversight: Establishing relevant KPIs to ensure targets are achieved (on-time delivery rates, deviation frequency, and so on)
    • Audits and assessments: Capability to periodically evaluate vendor compliance with GMP and GDP, and identify areas for improvement
    • Communication protocols: Managing the communications channels for shipment tracking, temperature monitoring, and incident reporting

Data compliance and privacy protection

The GDPR Act provides the most comprehensive data protection framework in the world [16]. Ensuring GDPR compliance is not optional; rather, it is a legal obligation, and there are penalties for non-compliance. Correct management of clinical trial data is therefore paramount to avoid such penalties, in addition to reputation damage and delays to your trial. The CRO is best placed to ensure your trial remains compliant.

How can we ensure compliance with the EU General Data Protection Regulation (GDPR)?

  • Lawful basis for processing: Defining the grounds for data collection and use via informed consent (forms must be clear, unambiguous, and available in the patient’s native language) and/or public interest in the area of public health
  • Data minimization: Collecting only the data needed for the trial, and the data must be kept anonymous. Some country-to-country variation does exist; for example, France does not allow the collection of race or ethnicity data
  • Data subject rights: Participants must be informed of their rights under GDPR, and have access to their data (and in some cases, removal of their data)
  • Cross-border transfer: Separate restrictions exist for transferring data from Europe to other regions to ensure adequate protection
  • Data security: Technical safeguards must exist to protect against unauthorized access or breaches

Do we need to appoint a local data representative or establish data processing agreements to comply with local regulations?

  • Yes – non-European/EU sponsors are subject to additional GDPR obligations, including (but not limited to):
    • EU data representative to act as the local point of contact for authorities and trial participants for all data protection issues
    • Data processing agreements must be signed between the sponsor and the CRO/vendors to ensure they act under the sponsor’s GDPR obligations and instructions
    • Data protection impact assessments need to be put into place for high-risk activities (such as clinical trials)

Key takeaways

Despite some logistical challenges, successful European trials only serve to enhance your global reputation. Established infrastructure, scientific credibility, suitable patient populations, and clear (if complex) regulation make running trials in Europe relatively straightforward – if you have the right knowledge to start with.

Executing the two key phases correctly and efficiently is crucial: Strategic planning involves identifying priority markets within Europe, understanding the regulatory landscape, selecting the right CRO to partner with, and ensuring the trial type is fit-for-purpose. Execution is the hard work – requiring robust coordination and local insights, many of which are provided by your CRO. Overcoming regulatory hurdles, such as CTR and GDPR requirements, is crucial.

Look out for the next installment in this series – how to run a clinical trial in the US, for the perspectives of global sponsors.

Contact PSI to discuss your European clinical strategy with our expert team

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Abbreviations

APAC, Asia-Pacific region;
ATMPs, Advanced Therapy Medicinal Products;
CAT, Committee for Advanced Therapies;
CEE, Central and Eastern Europe;
CRO, Contract Research Organization;
CTIS, Clinical Trials Information System;
CTR, Clinical Trials Regulation;
EMA, European Medicines Agency;
EU, European Union;
FDA, Food and Drug Administration;
FPI, first patient in;
GCP, Good Clinical Practice;
GDP, Good Distribution Practice;
GDPR, General Data Protection Regulation;
GMP, Good Manufacturing Practice; ICH,
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use;
IMP, investigational medicinal product;
KOL, Key Opinion Leader;
KPI, key performance indicators;
PD, pharmacodynamics;
PI, Principal Investigator;
PK, pharmacokinetics;
PRIME, priority medicines;
QP, Qualified Person;
US, United States (of America);
WE, Western Europe.

Referencess

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2. Citeline Inc. Data query. 2025.
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13. European Commission. Entry into application of the Clinical Trials Regulation. 2025 November 2025]; Available from: https://health.ec.europa.eu/medicinal-products/clinical-trials/entry-application-clinical-trials-regulation_en.
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