Expert Consulting And Multi-Regional Clinical Trial (MRCT) Strategy Rescues Oncology Program

A Chinese-based biotech sponsor specializing in innovative immunotherapy treatments faced setbacks in its US Phase 1 study for Advanced/Metastatic Solid Tumors. Seeking a solution, the sponsor enlisted Novotech for pre-clinical and comprehensive clinical CRO services to salvage the program based on the company's diverse capabilities, regional strength in the Asia-Pacific region, and global CRO abilities for managing the US arm of the study.

Implementing a Multi-Regional Clinical Trial (MRCT) strategy in the Asia-Pacific region, Novotech was able to optimize Investigational Product (IP) data collection for Phase 2 planning. Launching a Phase 1 escalation study in Australia capitalized on streamlined regulatory pathways, resulting in a rapid study start-up and a 45.3% R&D cashback incentive. Simultaneously, study arms were initiated in Singapore and South Korea, leveraging rapid regulatory timelines and abundant patient pools.

Uncover how Novotech's interventions yielded significant outcomes, including uncovering missing data through IB review, streamlining dosing timelines, and achieving successful recruitment milestones across Australia, South Korea, and Singapore by accessing the case study below.