Beyond Survival: How Ukraine's Clinical Research Sector Is Setting New Standards for Operational Excellence Under Fire

As pharmaceutical companies reassess their global trial strategies, Ukraine's clinical research ecosystem has emerged not just as a survivor of the world's most challenging operating environment, but as an unexpected benchmark for regulatory efficiency and operational innovation.

The numbers tell a story that defies conventional wisdom about conducting clinical research in conflict zones. According to the latest official data from Ukraine's State Expert Center, 324 clinical trials remained active as of January 2025 — a figure that represents not just continuity, but genuine growth from the depths of the crisis.

The Metrics of Resilience

While competitors focus on Ukraine's "quiet comeback," the real story lies in the operational data that reveals systematic excellence rather than mere recovery: "The statistics reveal something remarkable," notes Igor Khytrychenko, Managing Director COREX Ukraine. "Ukrainian investigators haven't just adapted to wartime conditions — they've used the crisis as a catalyst to eliminate inefficiencies that had plagued the system for years."

Operational Excellence Through Crisis

The transformation isn't accidental. Ukraine's Ministry of Health implemented dedicated email channels for different aspects of clinical trial management, creating digital workflows that many peacetime regulatory systems lack:

• dec@dec.gov.ua for trial lifecycle management
• evikno@dec.gov.ua for new study applications
• kv@dec.gov.ua for protocol materials and amendments
• clinic@dec.gov.ua for safety reporting

This digital infrastructure supported processing 1,213 incoming correspondences in the first half of 2025 alone, including 377 regulatory referrals and 836 information letters — all while maintaining compliance with international standards.

“We’ve seen Ukrainian teams process regulatory submissions faster than some Western European counterparts,” says Mark Woolf.
“When survival depends on efficiency, you eliminate bureaucratic waste quickly.”

The Economics of Trust

The financial implications extend beyond immediate cost savings. Ukraine's universal healthcare limitations create a patient population with significant unmet medical needs, while ongoing reconstruction and economic development needs require foreign investment and technology transfer — making clinical trials a strategic economic priority.
Recent data shows Ukrainian investigators maintained high retention rates even during active conflict, with only 42 early trial terminations in 2024, compared to 132 in 2022 at the height of the crisis. Of these, only 12 were war-related — the remainder due to standard reasons like low efficacy or economic factors.

Advanced Therapy Leadership

Perhaps most significantly, Ukraine has positioned itself at the forefront of advanced therapy research. The 4 Advanced Therapy Medicinal Product applications submitted in 2024 represent CAR-T cell therapies for systemic sclerosis, lupus nephritis, and various cancers — placing Ukrainian sites alongside leading international centers for breakthrough treatments.

"Ukraine's rapid adoption of advanced therapy protocols shows institutional confidence in their capabilities," notes Mark Woolf. "These aren't low-risk, routine studies. Sponsors only place cutting-edge trials where they trust the infrastructure completely."

Rebuilding During Conflict

The State Expert Center's methodology work during 2024 included development of three new regulatory guidelines aligned with EMA standards, plus translation and publication of international best practice documents. This suggests systematic investment in long-term capacity building rather than mere crisis management. Training statistics support this interpretation: 651 professionals attended GCP training in 2024, up from 403 in 2023 — indicating expansion rather than mere maintenance of the qualified investigator pool.

"What impresses me most is the forward-thinking approach," says Igor Khytrychenko. "Ukrainian regulatory authorities aren't just maintaining wartime operations — they're building improved systems even while the conflict continues. The efficiency gains forced by wartime necessity are being institutionalized as permanent competitive advantages."

Strategic Implications for Global Sponsors

The Ukraine experience offers three critical lessons for global clinical development strategies:


"The question for sponsors isn't whether Ukraine is 'safe enough' anymore," concludes Mark Woolf. "It's whether they can afford to ignore a regulatory environment that's eliminated inefficiencies other markets haven't even identified yet."

As the global pharmaceutical industry faces increasing pressure for faster approvals and cost optimization, Ukraine's clinical research sector hasn't just survived an existential crisis — it has emerged as an unexpected model for operational excellence that challenges industry assumptions about what's possible under pressure.

The real story isn't about recovery. It's about transformation.

COREX maintains active operations across Ukrainian clinical trial sites and continues to support advanced therapy and patient access programs throughout the region. For operational insights and case studies from Ukraine's evolving clinical research landscape, contact COREX at info@corexpharm.com

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