Case Study: Large Pharmaceutical Company achieves FDA approval three months ahead of schedule with IQVIA Biotech

Oncology Expertise Facilitates Accelerated Timeline

Large Pharmaceutical Company acquired two global Phase III prostate cancer trials mid-study and needed to accelerate the program, meet stringent data and regulatory requirements, and submit an interim database lock to the FDA. IQVIA (via IQVIA Biotech and IQVIA Recruiting & Staffing Solutions) was engaged to operationalize new sponsor priorities, manage rapid patient accrual, and preserve GCP and regulatory integrity under a compressed timeline.

IQVIA deployed an expanded clinical-monitoring SWAT team across 15 countries, added internal CRA resources, implemented custom data-quality reporting and escalation plans, and convened senior executives daily to drive progress. In four weeks (versus the typical 12) IQVIA completed the interim database lock — entering/monitoring 24,000 forms, closing 14,000+ queries, delivering a full TLF package with a 45% timeline reduction — enabling FDA approval three months ahead of the planned six-month schedule and subsequent EU approval.