A more efficient path to qualified Vendors

Vendor qualification in clinical trials has long been a slow, costly, and redundant process. Diligent’s centralized model reduces the burden on both Sponsors and Vendors while meeting the risk-based standards regulators require.

Talk to Sales

The Challenge

The traditional qualification model is holding the industry back

ICH E6(R3) is clear: Sponsors are responsible for assessing Vendor suitability, documenting qualification, and taking a risk-based approach to managing every partnership. In practice, the way most organizations fulfill that obligation creates significant inefficiency. 

In the typical process:

ICH E6(R3) is clear: Sponsors are responsible for assessing Vendor suitability, documenting qualification, and taking a risk-based approach to managing every partnership. In practice, the way most organizations fulfill that obligation creates significant inefficiency. 

In the typical process:

01

Sponsors send Vendors qualification questionnaires or commission formal audits — often through internal staff or third-party consultants 

Sponsors send Vendors qualification questionnaires or commission formal audits — often through internal staff or third-party consultants 

02

The same Vendor undergoes this process repeatedly, once for each new Sponsor relationship

The same Vendor undergoes this process repeatedly, once for each new Sponsor relationship

03

Qualification timelines stretch to months as Vendors manage competing audit requests from multiple clients 

Qualification timelines stretch to months as Vendors manage competing audit requests from multiple clients 

Result

Delayed trial start-up, redundant spend, and a growing compliance burden for everyone involved.

Delayed trial start-up, redundant spend, and a growing compliance burden for everyone involved.

Our approach

A modernized approach to Vendor qualification 

Diligent entered the clinical trial space to address this costly dysfunction in Vendor qualification. Rather than operating as a traditional audit firm—producing one-off reports for a single client—Diligent built a centralized platform where qualification work is performed once annually and the results are made accessible to all participating Sponsors, with full Vendor consent. 

Diligent entered the clinical trial space to address this costly dysfunction in Vendor qualification. Rather than operating as a traditional audit firm—producing one-off reports for a single client—Diligent built a centralized platform where qualification work is performed once annually and the results are made accessible to all participating Sponsors, with full Vendor consent. 

This model is not a regulatory workaround. Our approach is accepted by the FDA, with every aspect of our qualification process built to align with global GxP standards. Our SMEs actively track evolving regulations so our clients can be sure they are adhering to the latest guidance.

This model is not a regulatory workaround. Our approach is accepted by the FDA, with every aspect of our qualification process built to align with global GxP standards. Our SMEs actively track evolving regulations so our clients can be sure they are adhering to the latest guidance.

The result

The industry’s trusted, independent qualification organization

Sponsors no longer wait months to get on a Vendor’s audit calendar. Vendors are no longer subjected to the same process for every new client. And the more companies that join the platform, the more everyone benefits.

For Sponsors

Qualify Vendors in days, not months

Find vendors, request Qualification Packages, and accelerate trial start-up without compromising on rigor. 

For Vendors

Qualify Once. Work with many.

Complete one Diligent qualification annually and share the results with any client or prospect.

For the industry

A stronger compliance standard

A rigorous, risk-based qualification model aligned with the standards regulators expect, built in step with evolving guidance.

A new standard

Enabling compliance and efficiency

Our model centralizes a historically fragmented process and raises the bar for compliant, risk-informed qualification.

Traditional Model

Each Sponsor separately qualifies the same Vendor.

Months to schedule audits; weeks to complete questionnaires.

Sponsors pay full rate for redundant work.

One-off auditor relationships; no shared infrastructure.

Sponsors responsible for updating questionnaires against current regulations and re-qualifying Vendors.

Diligent Model

Rigorous qualification is completed annually and shared with qualifying Sponsors, with full Vendor consent.

Questionnaires and audit reports available in days.

Average 60% qualification cost savings.

Expert-led, independent qualifications centralized in one platform, with portfolio-wide risk intelligence.

Questionnaire templates mapped to the latest regulations available to all; Vendors update their information as templates change.

our capabilities

Complete Vendor Lifecycle Support.

Vendor strategy 

Build a sourcing strategy grounded in your trial's risk profile. Identify Vendors aligned to regulatory expectations and study requirements.

Vendor qualification 

Vendor qualification

Assess Vendor capabilities, quality systems, and compliance history through Diligent's centralized qualification process and expert auditors.

Vendor selection

Make confident, documented selection decisions based on quality, risk, cost, and fit for your specific trial.

Vendor oversight 

Stay ahead of performance issues with continuous monitoring, defined governance, and real-time risk visibility.

Vendor audits 

Verify Vendor compliance through independent, risk-based audits aligned to GCP and current regulatory requirements.

See the Diligent model firsthand

Our team is ready to show you how you can streamline qualification without compromising on compliance.

Book a demo