Case Study: A Clinical-Stage Biopharmaceutical Company achieves 10-week FPI and 4-month patient enrollment for Phase II prostate cancer with IQVIA Biotech

Study Start Up and Enrollment

A Clinical-Stage Biopharmaceutical Company engaged IQVIA (IQVIA Biotech) to run its Phase II prostate cancer trial in the U.S. after dissatisfaction with a prior CRO. The sponsor sought an oncology-dedicated CRO with prostate cancer expertise, protocol guidance, flexibility, and transparent trial execution to overcome competing investigator input, tight regulatory and contract timelines, many academic sites, and an aggressive First Patient In (FPI) goal tied to corporate funding milestones.

IQVIA Biotech provided oncology-focused study start-up and enrollment services—offering protocol input, site contract negotiation, regulatory coordination via its ISSC team, and rapid database build and eCRF implementation. IQVIA met the 10‑week FPI target with a live database, secured a waiver that saved nearly three weeks, and completed patient enrollment in four months (versus the projected 12 months); as a result, the sponsor chose to work exclusively with IQVIA on multiple upcoming Phase II and III trials.