Vendor Qualification: 20 Critical Questions Sponsors Should Ask

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

The rigor of your Vendor selection and qualification process will shape your compliance posture for the entire study. This guide provides 20 questions you should ask any clinical Vendor, covering critical areas to help you comply with ICH E6(R3) and other key regulations.

What's covered:

• Computer System Validation & Maintenance

• Data Integrity

• Data Management

• Personal Data Protection

• Risk Management

• Vendor Oversight

• & More

Use it as a starting point for qualifying new Vendors and building a consistent evaluation process across your program.

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.