Progressing From Single Country Phase 1 Success To Securing A Multinational Phase 1/2 Clinical Trial

A French-based biotechnology sponsor specializing in advancing immunotherapies for cancer patients, particularly those with Non-Hodgkin's Lymphoma and solid tumors, selected Novotech as its strategic partner for clinical trial management.

In the Phase 1 Single Country study for solid tumors in South Korea, Novotech successfully achieved targeted patient enrollment, reaching the crucial Last Patient Last Visit (LPLV) milestone. Their dedication, responsiveness, and high standard of work garnered praise from the sponsor.

For the upcoming Multinational Phase 1/2 trial spanning 10 sites for Phase 1 and 34 sites for Phase 2, Novotech tailored an efficient approach covering regulatory compliance, pharmacovigilance, and medical monitoring. Anticipated outcomes included swift regulatory approvals, accelerated timelines, and strengthened relationships with Principal Investigators, expediting critical milestones and offering tangible benefits to the sponsor.

Explore how this partnership aims to contribute to the success of the trial by leveraging global resources and streamlining processes for efficient and timely results.