Positioning A Sponsor's First Trial For Success: A Comprehensive Planning Approach For Cancer Antibody

A biotechnology company in the clinical development stage was working on its inaugural Phase I protocol for an immuno-oncology antibody intended for patients diagnosed with advanced solid tumor malignancies who have exhausted all conventional treatment options.

While searching for help to accelerate pathways for development and regulatory review, the biotech decided to collaborate with Veristat. Initially engaged in protocol development and study design, Veristat continued to serve as an advisory partner, offering valuable support in strategic consulting and assisting with regulatory strategy and planning, as well as biostatistics and programming, data management, quality assurance, and project management.

Access the case study below to see how the clinical-stage biotech company was able to facilitate expedited routes for developmental progress and regulatory assessment of their first Phase I protocol for an immuno-oncology antibody.