Case Study: Leading Private Biologics Company achieves rapid FPI and 30-day database launch with IQVIA Biotech

Leveraging Expertise to Exceed Immunotherapy Customer Goals

Leading Private Biologics Company engaged IQVIA Biotech to run its Phase I, multi-center immunotherapy study of a PD‑1 inhibitor. The sponsor needed an oncology‑experienced CRO to support protocol design, manage complex PK considerations, and accelerate start‑up to meet a 60‑day First Patient In (FPI) milestone while also launching the study database rapidly.

IQVIA Biotech’s Investigator Strategy and Site Coordination (ISSC) and Data Operations teams ran IRB submissions at risk, used a mix of local and central IRBs, identified PIs experienced with PD‑1 compounds, and executed a split database deployment to build the database in 30 days (vs a typical 90). As a result, IQVIA Biotech achieved FPI in eight weeks, had database Go‑Live 30 days after protocol completion, enrolled the first cohort three weeks later, and resolved an FDA query without a protocol amendment, enabling the sponsor to meet its critical milestone.