Case Study

Expert Consulting & Intelligent MRCT Strategy Rescues Oncology Program

Source: Novotech
GettyImages-1411002384 consulting

While pursuing novel immunotherapy treatments, a Chinese Biotech’s US Phase 1 study in Patients with Advanced/Metastatic Solid Tumors was beginning to fail. In 2020, the sponsor engaged Novotech to rescue the clinical trial by providing pre-clinical and full-service CRO activities.

Access this case study to discover how missing IB data and necessary additional details needed to outline US study challenges as required for local authority approval were identified and how a revised study design was able to reduce the dosing timeline and save the sponsor 40 days.


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