A multinational Phase III, randomized, double-blind, placebo-controlled IPF study conducted across Australia, South Korea, Hong Kong, and Taiwan, supported by Novotech’s coordinated regional operations, regulatory expertise, and rigorous site performance governance.
Case study overview
A U.S.-based pharmaceutical sponsor engaged Novotech to support Phase III IPF execution across four Asia-Pacific regions, building on an established relationship. Novotech provided end to end regional clinical operations and project management, led regulatory and ethics coordination, and provided site management and monitoring support, with close sponsor alignment to ensure consistent execution across jurisdictions.
Recruitment was primarily driven by South Korea, while variability at a small number of sites reinforced the value of robust feasibility assessment and ongoing enrollment forecasting. Centralized governance and frequent alignment touchpoints supported timeline adherence and sponsor visibility throughout recruitment.
Study footprint at a glance
- Sites: 25 total (Australia 7; South Korea 9; Hong Kong 4; Taiwan 5)
- Patients enrolled: 80
- Recruitment period: 28 months
- Enrollment concentrated in South Korea (65 patients across 9 sites)
Download the case study infographic to review outcomes, country-level performance, and execution insights for Phase III IPF trials across APAC.