A private biologics company needed a specialized oncology CRO to manage its Phase I, multi-center study to evaluate the safety and pharmacokinetic (PK) profile of an immunotherapeutic drug in subjects with advanced solid tumors. The Senior Director of Clinical Operations was searching for an oncology-experienced clinical trial partner that could support protocol design and accelerate the start-up process to meet a quick First Patient In (FPI) milestone. Following a competitive review, the sponsor selected IQVIA Biotech based on our ability to deliver adaptive trial design, demonstrated extensive oncology expertise, flexibility and understanding of nuanced immunotherapy drug trials.
Every study has its unique set of challenges and, in this case, it was timing. The customer needed FPI of 60 days in order to meet an internal stakeholder commitment. Continue reading to learn how the IQVIA Biotech Investigator Strategy and Site Coordination (ISSC) team created a comprehensive plan to manage the start-up process and meet the customer’s expectations.