Streamlining Phase I/II Oncology Trials: A Global CRO Partnership For Success

A European biotech sponsor developing an antibody-drug conjugate (ADC) therapy for advanced solid tumors faced significant challenges in conducting an adaptive Phase I/II dose escalation and expansion study in the U.S. To ensure a seamless trial execution, the sponsor partnered with TFS HealthScience (TFS), leveraging its global capabilities and early-phase oncology expertise.

TFS assembled a specialized project management team, balancing real-time communication between a Europe-based project manager and a U.S.-based clinical trial team. The study required efficient site activation, clinical monitoring, and seamless cohort management. TFS implemented a streamlined approach that enhanced slot assignment, accelerated patient enrollment, and minimized screen failure rates. To ensure compliance and inspection readiness, TFS maintained high-quality monitoring visit documentation and Trial Master File (TMF) oversight. The integration of cost-effective European back-end support further improved trial efficiency. As a result, U.S. sites achieved the highest enrollment rates with the lowest screen failure rates. Through strategic planning, adaptive trial execution, and proactive collaboration, TFS successfully navigated the complexities of this early-phase oncology study, reinforcing its reputation as a trusted global CRO partner.