Key Takeaways:
Understanding the European Clinical Trials Regulation (CTR):
Korean biotechs need to adapt to the harmonized regulatory framework under CTIS while managing country-specific nuances. The EMA offers strong IP protection and transparency, but cost variation and bureaucratic hurdles remain.
Strategic Location Selection:
Central and Eastern Europe—especially countries like Poland and Hungary—offer affordable trial environments and access to diverse patient populations. However, inflation and recruitment delays must be accounted for in budgeting and planning.
Importance of CRO Partnerships:
Engaging a CRO with deep regional expertise, such as Novotech, is critical. These partners help navigate local regulatory landscapes, accelerate site startup, and ensure compliance—especially valuable for biotechs with limited in-house global trial experience.
Tailored Recruitment Strategies:
Rare disease trials in Europe benefit from treatment-naïve populations in CEE regions, but recruitment gaps can hinder timelines. Biotechs must deploy patient-centric, region-specific recruitment strategies to ensure success.
Korean biotechs entering the European market can improve clinical trial success by selecting cost-effective sites, understanding the evolving CTR, and collaborating with seasoned CROs. With the right strategy and support, companies can accelerate trial timelines and boost their global footprint.