Challenge

A US-based oncology start-up had its datasets scattered across multiple vendors:
• ADME from CRO A
• PK from CRO B
• Toxicology from CRO C
• CMC from an Indian CDMO
Data formats, units, and study designs were inconsistent, and the IND deadline was 7 weeks away.

The Intervention

• Performed a complete data integrity assessment
• Reconciled and harmonised all datasets (units, formats, raw data alignment)
• Cross-checked findings with FDA guidance
• Rebuilt pharmacology & PK narratives for IND
• Coordinated gap-filling experiments with a rapid-turnaround CRO
• Conducted final IND quality check before legal submission

Outcome

• IND submitted ahead of deadline
• Sponsor received Zero FDA Information Requests (IRs)
• Program advanced to FIH Phase I
• Sponsor raised follow-on funding based on the clean regulatory package

Impact

A fragmented, high-risk submission turned into a clean, regulator-ready IND.

Why Aventiq Bio

Instead of learning from painful vendor switches, pharma and biotech sponsors can de-risk their India outsourcing strategy from day one.