Poland has opened a new university clinical trial support centre in Warsaw as the country seeks to attract more international research projects at a time when Europe is steadily losing ground in the global clinical trials market.
The University Clinical Trials Support Centre at the Medical University of Warsaw received around €7 million in public funding and is expected to streamline the organisation of clinical research by supporting investigators, sponsors and patients throughout the entire trial process.
“Launching the University Clinical Trials Support Centre sends an important signal to the entire market,” Michał Byliniak, director general of INFARMA, the Polish association of innovative pharmaceutical companies, told Euractiv.
“Such centres professionalise the conduct of clinical trials, improve cooperation between sponsors, investigators and patients, and strengthen Poland’s ability to attract advanced research projects.”
Europe losing ground
The investment comes as Europe faces mounting pressure to remain competitive in clinical research. According to INFARMA, Europe’s share of industry-sponsored clinical trials has fallen from 22% to 12% over the past decade as sponsors increasingly shift research towards faster-moving markets in North America and Asia.
“Competition for clinical trials is now global,” Byliniak said. “Sponsors look not only at scientific excellence and patient populations, but also at organisational efficiency, research infrastructure and the predictability of regulatory processes.”
Despite the broader European trend, Poland has emerged as one of the continent’s strongest clinical research hubs. Industry data show the country ranked sixth in the EU and ninth globally for commercial clinical trials in 2024. The sector generated more than $2.2 billion in economic value, supported around 9,400 jobs, and provided nearly 26,800 patients with access to innovative therapies.
Officials say the new centre is intended to build on these strengths rather than simply expand existing infrastructure.
Speaking at the inauguration, Marcin Iskra, director general at Poland’s Ministry of Science and Higher Education, said the project goes beyond coordinating clinical trials.
“The ambition is to create a model that integrates patient care pathways with access to the most advanced therapies while improving data management and analysis through artificial intelligence,” he said.
The centre also plans to develop digital research infrastructure and introduce AI-supported tools that comply with data protection and cybersecurity requirements.
Tackling the system’s weakest links
For industry representatives, the biggest obstacle is no longer scientific expertise but the speed and organisation of the system.
According to INFARMA, faster study start-up procedures, closer coordination between institutions and continued investment in research infrastructure could generate hundreds of millions in additional economic value while giving patients earlier access to innovative treatments.
“Clinical trials are not a cost to the healthcare system,” Byliniak added. “They are an investment in patients, physicians, science and the economy.”
The new centre hopes to address precisely these bottlenecks by acting as a single operational hub for researchers and industry partners.
“Our goal is to create a single point of contact,” said Professor Łukasz Kołtowski, director of the University Clinical Trials Support Centre. “Sponsors and investigators should receive support throughout the entire process – from the initial idea and feasibility assessment to contracts, project delivery and final settlement.”
The consortium brings together several hospitals affiliated with the Medical University of Warsaw, representing almost 2,000 hospital beds, more than 160,000 hospital admissions and over half a million outpatient consultations annually.
The centre has already begun operations. During its first three months, it signed 13 clinical trial agreements, while another 37 projects remain under evaluation, and 16 feasibility assessments have already been submitted to sponsors.
Faster approvals remain essential
Even with stronger infrastructure, experts argue that Poland will struggle to compete internationally unless administrative procedures become significantly faster.
Speaking at the launch, Ernest Szubert, president of GCPpl, described contracting with public hospitals as the sector’s biggest weakness.
“Our Achilles’ heel is contracting clinical sites,” he said. “It often takes months, sometimes more than a year. My personal record is two years with a public hospital, and that’s something we need to address as quickly as possible.”
He also pointed to the slow digital transformation of clinical research.
“Poland is considered digitally advanced, yet we still encounter sites relying entirely on paper documentation instead of electronic records and e-consent systems,” Szubert said.
Szubert noted that previous industry estimates, introducing a 14-day fast-track approval process for early-phase clinical trials could attract more than 300 additional commercial studies annually, generate around €61 million in added economic value and save Poland’s National Health Fund (NFZ) almost €23 million each year.
[VA, BM]