Vendor Qualification: 20 Critical Questions Sponsors Should Ask

Ask the right questions. Stay current. Build a consistent process.

The Vendors you select at trial startup will shape your compliance posture for your entire study. This guide provides 20 questions to ask any Vendor — covering critical areas regulators and auditors scrutinize, updated to reflect ICH E6(R3) and other current applicable regulations and guidance. 

Use it to qualify new Vendors and build a consistent evaluation process across your program.

What's covered:

• Computer System Validation & Maintenance

• Data Integrity

• Data Management

• Personal Data Protection

• Risk Management

• Vendor Oversight

• & More

Sponsors on Diligent360 get access to current and comprehensive qualification information across GxP Vendor categories with side-by-side Vendor comparisons built into the platform. Our SMEs conduct comprehensive risk scoring tailored to your trial criteria and study needs, so you can identify the right Vendors and make decisions with confidence.