Frequently Asked Questions by Service Providers

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For FAQs by trial sponsors, please click here

How does the Diligent Qualification Platform® work?

Our team qualifies clinical trial technology and service providers—for both pharma and biotech clients and at the proactive request of providers—using a rigorous, standardized approach. The outputs of that qualification—the audit report and answers to Qualification Questionnaires (RFIs)—reside on our secure technology platform and are readily available for other trial sponsors to request and download.

How is confidentiality and data protected? What can competitors see?

Providers retain complete control over their RFI documents and qualification audit report and must approve of their release whenever a sponsor submits a request.

When a sponsor wants to qualify a provider by accessing RFI documents or an audit report, they submit a request through the Platform. Data is not transferred withough the provider’s explicit approval. Providers can also update RFI documents and add an addendum before releasing their audit report with a real-time update on material business changes and the status of CAPA implementation. 

Your qualification credentials remain confidential. Other providers are not able to ever request or access your information.

How is using existing audit reports a credible and acceptable way to qualify providers?

ICH Q9, ICH Q10, and ICH E6 leave the vendor qualification method up to trial sponsors, and the industry has long relied on independent audits to qualify the same providers. Our FDA-accepted cooperative audit model eliminates the need for separate auditors, styles, and findings, resulting in cost savings and accelerated risk management without compromising compliance. For some, qualification is a box to be checked, but Diligent was founded as an independent third-party auditor to inject objectivity and precision into this crucial process.

Has the FDA reviewed Diligent’s model?

The FDA has reviewed Diligent’s centralized model and accepts pharma and biotech’s use of our cooperative audit model as a compliant way to qualify providers.


After we join Diligent, what happens if a trial sponsor sends us their own RFI/Qualification Questionnaire (outside of the platform)? Are we obliged to use Diligent only to answer RFI requests?

There is no restriction in our agreement to prevent you from answering an RFI outside of Diligent. We’d appreciate it if you tell other sponsors about Diligent as a faster and easier way to get complete information about service providers. 

What would be the process for us to join Diligent?

Firstly you would execute a Provider Agreement with us. Then we will grant you access to the Diligent platform and train you – plus your team if needed – on how to use it.

In the meantime, we will send you the Core RFI questionnaire in Excel format so that you can start to collect your answers. When complete, we will review and upload your answers to the platform for you. Your profile on the platform would then be complete and visible to sponsors looking to qualify service vendors. You will also be able to fill in your responses to any specific RFIs for services that you provide, either through a spreadsheet or directly in the Platform.

How does a provider complete the RFI?

You will have access to the platform and will input your responses to the standard questions contained within the RFI. You can do so directly into the platform or choose to add your answers to an Excel sheet and upload that to the platform. After a review by the Diligent team, your answers will be uploaded to your profile on the Platform.

If I use a spreadsheet, could I update it as things change?

Your RFI content is stored and managed within the Diligent platform, so no spreadsheet changes will be reflected until you input those changes into the platform. Once you update an RFI in the platform, sponsors who previously requested the relevant RFIs from you will be notified of those updates.

Referencing a central database for vendor information is only valid during the time of data collection. When Vendor key personnel and SOPs change, is another qualification required?

Every request for information (RFI) from a sponsor is sent to you. Once received, you have the opportunity to refresh the details before releasing it to the sponsor. Rather than having to recreate all the RFI content, you can focus on the areas that have changed since the previous update. This enables a resource efficient methodology for getting out the latest information.

How often do you perform assessments onsite vs questionnaire or virtual?

During the COVID-19 Pandemic, almost all of our vendor qualification assessments (VQAs) were conducted remotely. Since then, sponsors & providers have started requesting and allowing onsite VQAs. At late 2022 approximately 20% of our VQAs are being planned as onsite, face to face assessments. We can do whatever our pharma clients request as long as the provider allows onsite visitors.

Let’s talk

Contact us for a conversation about joining the Diligent Provider Community. Please fill out the form below or email Ray Lloyd at

The Diligent platform will simplify and streamline your provider selection and qualification processes