A mid-sized biotech developing an innovative therapy for metastatic breast cancer faced one of oncology’s most competitive landscapes, while navigating significant organizational change and aggressive corporate timelines. The global Phase Ib/II umbrella trial spanned multiple treatment cohorts and combination therapy arms across ~140 sites in 16 countries, with new cohorts continually added as standards of care evolved. Challenges were formidable; they included an already-approved therapy risked off-label prescribing that could complicate enrollment, full Master Services Agreement requirements threatened to delay activation, and the sponsor’s first use of CTIS for European submission added regulatory complexity across challenging geographies.
Worldwide Clinical Trials responded with a highly coordinated operational strategy designed to accelerate startup while maintaining study quality. Multiple workstreams, including study setup, contractual negotiations, regulatory activities, and site readiness, all advanced in parallel, supported by established relationships with high-performing oncology and Global Alliance Collaboration sites. The team guided the sponsor through its first CTIS submission and supported ongoing protocol amendments with real-time competitive analysis. As a result, we initiated the first site within six weeks over a holiday period, had first patient in the day after IP arrived, met or exceeded enrollment goals across all cohorts, and maintained inspection-ready data throughout. Despite constant change, Worldwide sustained performance and helped the sponsor move quickly, adapt, and maintain momentum.
Read the full case study to learn how Worldwide:
- Coordinated parallel startup workstreams to compress timelines without sacrificing quality
- Navigated global regulatory complexity, including a first CTIS submission across 16 countries
- Maintained inspection-ready data and enrollment momentum through ongoing protocol amendments and evolving standards of care
