7 Reasons to Choose Central and Eastern Europe as Your Go-To Destination for Clinical Trials

The global market for CROs is booming, projected to grow from $52.19 billion in 2023 to approximately $68.92 billion by 2027. Despite this growth, many clinical trials face significant delays, with 80% running behind schedule, leading to substantial financial losses. To address these challenges, rapid and effective strategies are often needed to rescue delayed trials.

Central and Eastern European (CEE) countries have emerged as ideal locations for both regular and rescue clinical trials, thanks to their fast enrollment capabilities and streamlined regulatory processes. With a large pool of treatment-na?ve patients due to specific national healthcare systems, CEE offers a robust environment for efficiently executing clinical trials and getting them back on track when needed.

The appeal of CEE in clinical research is also reflected in the growing number of trials being conducted in the region. According to data from ClinicalTrials.gov, the number of studies in CEE has increased significantly, with 2,260 trials initiated in 2021 and nearly doubling to 4,351 in 2023. This growth highlights the region’s rising prominence in the global clinical research landscape.

In this article, we will explore seven reasons why CEE is becoming a favored destination for clinical trials and its critical role in the global CRO market.

1.???? CEE's Crucial Role in FDA Approvals

In 2022, the FDA’s Center for Drug Evaluation and Research approved 37 new drugs, with 29 of them undergoing clinical trials in Central and Eastern Europe. This trend continued into 2023, where 41 out of 55 FDA-approved drugs (75%) being tested in CEE countries, either exclusively or alongside other regions. This underscores the pivotal role CEE plays in global clinical trials, especially for pharmaceutical companies seeking FDA approval.

Moreover, the involvement of at least one European Medicines Agency (EMA) country in late-phase clinical trials is critical for obtaining Marketing Authorization Applications (MAA) in the EU. Including CEE countries in the trial process enhances the regulatory submission process and ensures a broader acceptance within the European market.

Below is a table detailing the CEE countries where these FDA-approved drugs were tested. It's important to note that a single drug might have been tested in multiple CEE countries, further underlining the region's pivotal role in the clinical trial process.

2.???? Proven Clinical Quality Standards

Clinical research in CEE adheres to high-quality standards, as evidenced by the results of FDA inspections. In 2024, 75% of all FDA inspections in CEE resulted in a "No Action Indicated" (NAI) outcome, demonstrating strong regulatory compliance. This compares favorably to the US and Western Europe, where the NAI rate is around 65%. The region’s adherence to strict regulatory standards ensures that clinical trials conducted in CEE are of the highest quality.

3.???? Large and Diverse Patient Pool

CEE offers a significant advantage for clinical trials due to its large and diverse population, which exceeds 250 million people. The region’s genetic diversity is beneficial for trials requiring a wide range of participants, enhancing the generalizability of trial results. Additionally, many CEE countries have healthcare systems that focus on large urban hospitals, streamlining patient recruitment.

Countries like Poland, Romania, Hungary, and Germany contribute significantly to this pool, making CEE an ideal choice for pharmaceutical companies aiming for broad and inclusive clinical trials. The combination of a large treatment-na?ve population and a centralized healthcare system facilitates efficient recruitment.

4.???? Streamlined and Harmonized Regulatory Processes

CEE's regulatory environment is increasingly aligned with European Union (EU) standards, thanks to the EU Clinical Trials Regulation (EU No 536/2014) and the implementation of the Clinical Trials Information System (CTIS). This harmonization has simplified the process of submitting and managing clinical trials across EU countries, offering faster approval timelines and reduced administrative complexity.

Since its introduction on January 31, 2022, CTIS has revolutionized the way multinational trials are conducted. Sponsors can now submit a single application for trials spanning multiple countries, streamlining the entire process. This system harmonizes regulatory procedures, ensuring that clinical trials conducted in CEE countries, as part of the EU, benefit from standardized regulations that promote faster approval timelines.

Under this system, clinical trial applications must be submitted through CTIS, where Parts I and II of the documentation are reviewed in parallel. This simultaneous review process typically takes about 6.5 weeks, leading to a total review and approval time of up to 8.5 weeks, with no Requests for Information raised during the review process. The result is a more predictable and efficient regulatory environment that encourages the initiation of clinical trials across multiple EU and EEA countries.

Beyond the EU, non-EU countries such as Georgia, Serbia, and Moldova have also developed robust regulatory frameworks that align closely with international standards. These countries typically achieve approval timelines of up to 10 weeks, reflecting their commitment to maintaining high regulatory standards while facilitating the conduct of clinical trials.

For multinational trials, particularly those targeting both FDA and EMA approvals, involving at least one EMA country in the trial process is critical for a successful MAA.

5.???? Fast Recruitment Rates

CEE stands out for its rapid patient recruitment in clinical trials, often running 2-4 months ahead of schedule compared to the US and Western Europe. This advantage makes the region highly attractive to companies seeking to meet their recruitment goals efficiently. The region's success is driven by several factors, including a large pool of treatment-naive patients, motivated investigators, and fewer competing trials.

6.???? Competitive Cost Advantage

The cost of conducting clinical trials in СEE is significantly lower than in the United States and Western Europe. On average, clinical trials conducted in CEE are 30% to 50% more cost-effective. This cost efficiency is due to lower operational expenses, such as site fees, investigator grants, and patient recruitment costs, without compromising the quality of data or compliance with regulatory standards. ?

7.???? Highly skilled and experienced clinical personnel

CEE is home to highly skilled and motivated clinical research professionals whose expertise rivals that of their counterparts in the US and Western Europe. The region's strict adherence to ICH-GCP standards ensures that trials meet global quality benchmarks. Investigators in CEE often have more time to dedicate to each study due to the lower density of trials, which enhances the quality of patient care and data collection.

Moreover, centralized healthcare systems in CEE countries channel patients into specialized centers, often large university hospitals, where clinical trials are concentrated. This structure facilitates efficient recruitment and ensures that investigators are highly experienced in conducting specialized research.

Cromos Pharma: Pioneering Clinical Research in Central and Eastern Europe

Cromos Pharma has been at the forefront of clinical research in Central and Eastern Europe since expanding its operations to the region. Established in 2004, we have built a strong track record of delivering successful clinical trials for global sponsors, supported by our deep expertise and commitment to excellence.

We manage a wide range of clinical trials across CEE, including innovative medicines, generics, and biosimilars. Our tailored services, combined with the region's high recruitment rates, enable us to consistently meet or exceed enrollment timelines. Cromos Pharma’s hybrid approach—leveraging both CEE and US capabilities—makes us an ideal partner for global sponsors, especially in later-phase trials that require diverse patient populations and regulatory alignment across multiple regions.

For inquiries or to explore how Cromos Pharma can enhance your next clinical project in CEE, please contact us at [email protected] We are dedicated to ensuring your research is executed with precision and efficiency.