Case Study: A Private Biologics Company achieves rapid First Patient In and 30-day database launch with IQVIA Biotech

Leveraging Expertise to Exceed Immunotherapy Customer Goals

A Private Biologics Company engaged IQVIA (via IQVIA Biotech) as its oncology CRO to manage a Phase I, multi-center immunotherapy study of a PD-1 inhibitor. The sponsor’s Senior Director of Clinical Operations needed rapid start-up to meet a First Patient In (FPI) milestone within 60 days, a database launch within four weeks, and feared delays from a late FDA question and the complexity of the compound and protocol.

IQVIA’s Biotech teams (Investigator Strategy and Site Coordination and Data Operations) executed an at‑risk site initiation strategy, used a mix of local and central IRBs, leveraged strong site relationships, and ran a split deployment to build the database from draft protocol. As a result, IQVIA delivered database Go‑Live in 30 days (versus a typical 90), achieved FPI in eight weeks, enrolled the first cohort three weeks later, and resolved the FDA query without a protocol amendment, meeting the sponsor’s tight timelines.