Revolutionizing Clinical Trial Service Provider Qualification

A Process Efficiency that Reduces Qualification Burden and

Accelerates Time to Revenue in an Increasingly Competitive Landscape

– A webinar for Clinical Trial Service Providers –

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Questions and Answers:

How is leveraging centralized qualification data a credible and acceptable way to qualify providers?

ICH Q9, ICH Q10, and ICH E6(R2) leave the qualification method up to trial sponsors, and the industry has long relied on independent audits to qualify the same providers.

The FDA has reviewed Diligent’s model and accepts pharma and biotech’s secure reuse of centralized qualification data as a compliant way to qualify providers.

Why should I trust the quality of Diligent’s work?

Each auditor on our team has 10+ years of GCP or GCLP experience and the appropriate technical expertise.

Several top ten pharma companies, with some of the most stringent quality standards, are current Diligent clients, leveraging our FDA accepted qualification model.

Our processes and detailed information exceed their internal expectations for vendor qualification.

Has the FDA inspected Diligent’s clients?

The FDA has inspected our clients with zero incidents related to the secure reuse of centralized qualification data.

Our qualification model holds up during the NDA/BLA process, as well.

Has Diligent been audited and qualified?

Yes, we’ve been audited by several big pharma clients.

These audits are conducted as needed depending on the sponsor and their SOPs regarding vendor qualification.

How can we implement the Diligent qualification
model if our SOPs don’t reference the reuse of
centralized qualification data?

Diligent’s Quality team will provide you with SOP language or modifications that allow you to implement our model into your existing qualification processes.

We’ve worked with many Sponsors across the industry to incorporate Diligent into their standard processes for ensuring a rigorous approach to risk-based vendor qualification.

SOP modifications have been very straightforward and nominal from our experience.