In a recent article, Novotech leaders Scott Schliebner, Vice President - Drug Development Consulting, and Renita Hite, Director Regulatory (Drug Development Consulting), share their insights on why ex-US clinical trials are becoming a strategic necessity.
With U.S. sponsors facing regulatory uncertainty, workforce shortages, and rising costs, ex-US development offers a proactive path to keep programs on track, expand patient access, and reduce risk.
Key Advantages
- Regulatory speed: Australia, South Korea, and other APAC markets offer faster approvals and efficient pathways.
- Patient access: Diverse, high-prevalence populations support rapid enrollment across oncology, rare disease, and infectious disease trials.
- Cost efficiency: Competitive pricing and reliable operations reduce delays tied to U.S. site constraints.
Novotech Expertise
With deep therapeutic knowledge, global site networks, and regulatory capabilities across APAC, North America, and Europe, Novotech helps sponsors de-risk programs with scalable, regionally integrated solutions.
Insights
- Scott Schliebner: Ex-US development is now essential for both speed and regulatory success.
- Renita Hite: Strong site partnerships and patient-focused engagement are critical to Novotech’s global trial delivery model.