The sponsor assessed the safety and tolerability of escalating oral doses of one drug, when combined with the standard dosing of another, in patients with advanced solid malignancies. The client : a global pharmaceutical group focused on developing prescription drugs that target unmet medical needs in numerous indications including oncology.
CHALLENGE: ADAPTIVE DESIGN
- After go-live, the sponsor learned its study did not fit the existing IRT solution, affecting data quality, timelines, and drug supply shipments. Following an RFP, the sponsor asked Cenduit to build a rescue study
- A key factor: the legacy system’s medication management algorithm could not support the required flexibility in the supply chain. The trial included an adaptive cohort design
- Cenduit delivered a high-quality study achieved through innovation, close client collaboration, and expert project management.