Francina Agosti, Author at Labiotech.eu

Today, Europe stands as a critical region for biotech companies looking to advance medical breakthroughs in specialized fields, including oncology, rare diseases, and cell and gene therapy. In particular, the Netherlands has emerged as a strategic gateway for clinical trials. With a highly integrated healthcare system, exceptional digital and logistical infrastructure, world-class academic centers, and a patient-centric approach, the country is well-positioned to support the rigorous demands of early-phase clinical trials as well as late-phase clinical trials. In this article, we explore why and how the Netherlands offers distinct advantages for biotech clinical trial execution, what challenges sponsors may encounter, and how Contract Research Organizations (CROs) can help ensure success for companies navigating the Dutch and broader European clinical research landscape. Why choose the Netherlands for biotech clinical trial execution? While the Netherlands is a small country of about 18 million people, it has 113 hospitals and eight internationally recognized academic medical centers. This extraordinary concentration creates a highly efficient and accessible environment for clinical trials. Combined with other strengths, the country is widely respected in the global healthcare community and is recognized as a leading player in the international life sciences sector. In a 2020 ranking, the journal Nature positioned the Netherlands in the top ten countries for life science research, primarily due to its prestigious academic medical centers, including the University Medical Center Utrecht, Amsterdam University Medical Center, and Erasmus Medical Center. These centers are also equipped for complex Phase I/II oncology studies, having a strong infrastructure to support first-in-human and adaptive designs, such as dose escalation studies. Besides academic and healthcare centers, the Netherlands is home to a robust venture capital ecosystem that actively supports biotech and life science innovation. Biotech Booster received €246 million from the Dutch government, which will be used to support start-ups that aim to translate scientific biotechnology findings into practical benefits for society. Moreover, the Dutch government committed €1.3 billion in funding with the goal of becoming a global biotech leader by 2040, expecting to give a startup booster that may lead to the creation of a biotech hub in Europe. In a 2025 biotech innovation score, the Netherlands already ranks as a top biotech country. Adding further depth to the country’s thriving biotech ecosystem, the Netherlands is home to the European Medicines Agency (EMA), located in its capital, Amsterdam, benefiting from a strong regulatory presence, attracting expertise, and facilitating alignment with European frameworks. Start-ups and small and mid-sized biotech companies are clustered in science parks in Amsterdam, Utrecht, Leiden, and Oss. Moreover, a number of these mid-sized life sciences companies have earned global recognition, particularly in the US. With its robust infrastructure and proven expertise in generating high-quality clinical trial data, the Netherlands is particularly well-suited for complex and early-phase studies in oncology, rare diseases, cell and gene therapies, and neurology. Building on this strong foundation, the country stands out as a leading European hub for advanced cell therapies such as CAR-T and TCR-T, supported by world-class leukapheresis/apheresis capabilities, state-of-the-art Good Manufacturing Practice (GMP) facilities, and hospital exemption programs that enable early, controlled patient access to innovative treatments. Dutch health centers are equipped with state-of-the-art technologies, and the country’s high level of English fluency ensures smooth communication across international teams. Its dense population accelerates patient recruitment by enabling relatively easy access to trial participants, while strong electronic health record (EHR) integration allows researchers and physicians to identify and engage niche populations with precision. The widespread implementation of tools like electronic Clinical Outcome Assessment (eCOA) and e-diaries further enhances trial efficiency and patient follow-up. Allucent: a partner enabling success in the Dutch and European clinical trial ecosystem Several Contract Research Organizations (CROs) have established long-term operations in the Netherlands to leverage its strong clinical trial ecosystem. Allucent —a global CRO focused on small and mid-sized biotechs with a global footprint spanning over 60 countries, including 26 offices— in particular, has a wealth of experience in The Netherlands, home to its European headquarters. With decades of practical experience and a dedicated Dutch team, Allucent combines deep regional roots with the expertise to deliver successful clinical trials in the Netherlands and beyond. Allucent leveraging Dutch infrastructure for complex clinical trials Bosch explains that Allucent also offers critical support to the sponsors in a collaborative environment, “Our teams bring therapeutic expertise, strategic foresight, and deep knowledge of the rapidly evolving clinical landscape, ensuring that our sponsor’s program benefits from best-in-class thinking at every stage, all the way from the RFP [Request for Proposal] stage to operational completion of the project,” she says. To ensure high-quality clinical trial performance, the CRO has built the “Allucent Centers of Expertise” or ACEs for specific complex therapeutic areas like oncology (including Antibody-Drug Conjugates, or ADCs), cell and gene therapy, rare disease, neurology, and infectious disease and vaccines, that serve as a strategic and operational hub of expertise. Allucent strategically utilizes the Netherlands’ strong infrastructure for conducting complex and innovative clinical trials. Particularly, in cell and gene therapies, it benefits from the country’s leading academic centers in Leiden, Amsterdam, and Utrecht, as well as prominent service providers like the Netherlands Center for the Clinical Advancement of Stem Cell and Gene Therapies (NecstGen) and Cytiva. Regarding oncology, the Netherlands hosts a high volume of clinical trials, anchored by top-tier institutions like the Netherlands Cancer Institute (NKI) and the Princess Máxima Center (PMC) for Pediatric Oncology, which also provides expert care for children and families participating in trials. Moreover, close collaboration between academia and industry, along with access to national cancer registries, supports the implementation of biomarker-driven studies and accelerates research in precision medicine, opportunities that Allucent is well-positioned to leverage. Bosch highlights that at Allucent, they are the right size to add value: “We are big enough to deliver yet small enough to care,” she says. “Known for our strategic partnerships with small and mid-sized biopharma, we leverage a nimble, cross-functional A-Team approach to streamline drug development from early-phase studies through post-marketing support,” she continues. “Our ACEs are not just a claim; our expertise in complex therapeutic areas like oncology, CGT, rare disease, among others, is proven through consistent, high-quality delivery, regulatory successes, and long-standing partnerships with biotech innovators.” Allucent’s regulatory excellence: EU clinical trial leadership In keeping with Allucent's adaptive and flexible approach, when in January 2022 the new European clinical trials regulations came into effect, changing the way clinical trials are regulated in the European Union (EU) and European Economic Area (EEA), the team acted fast: “We were early movers compared to some of the other stakeholders,” says Raymond Hoffmans, Vice President, Corporate Services at Allucent. He explains that Allucent did the first submission in the Clinical Trials Information System (CTIS) in May 2022. “Within a few months, we were able to create new procedures/SOPs [Standard Operating Procedures] as well as to align our Study Start-Up (SSU) team structure internally to specifically address the needs of this European Clinical Trial Regulation (CTR) application,” adds Hoffmans. Allucent relies on its in-house global regulatory managers who participated in the EMA training program in Europe. “We have a dedicated local team of experts specializing in CTA [Clinical Trial Application] and CTR submissions,” says Hoffmans, adding that Allucent has managed submissions for a wide range of modalities, including cell and gene therapies, radiopharmaceuticals, chemicals, small molecules, antibodies, and other antibody-like molecules. Conclusion For biotech companies seeking more than just a trial location—but a true strategic partner in Europe—the Netherlands offers an ideal entry point to both clinical and commercial success, especially when paired with the right CRO. With its global reach, deep local expertise, patient-centric approach, and focus on high-quality, agile execution, Allucent is uniquely positioned to help biotech sponsors navigate the Dutch clinical trial ecosystem and scale across Europe and beyond. Partner with Allucent to navigate the Dutch clinical trial landscape and accelerate your path to success.