A modernized approach to Vendor lifecycle management

We all know that in our heavily regulated industry, Sponsors must rigorously qualify a company before entrusting them with trial activities. They must assess that Vendor's suitability, confirm they have the appropriate systems in place, and document the entire qualification process. ICH E6(R3) is explicit: risk-based qualification is required, and that responsibility sits with the Sponsor. 

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how it works

How does this work in practice?

Sponsors typically qualify Vendors through questionnaires or formal audits, often conducted by internal staff or consultant auditors. For smaller companies with limited internal resources, third-party consultants are especially common. The result is slow, costly, and redundant: every Sponsor runs essentially the same process on the same set of Vendors, creating a compounding burden that grows as Vendors take on more clients. 

Diligent entered the market as a specialized qualification consultant, qualifying Vendors on behalf of Sponsor clients through proprietary Qualification Questionnaires and Diligent-conducted audits. Over time, a clear pattern emerged: performing a full qualification audit of a lab or CRO for one client, only to repeat the exact same process for the next, was an unsustainable model. Diligent centralized this qualification process. Rigorous due diligence is performed once, with full Vendor consent, and the results are made available to all qualifying Sponsors. 

Sponsors typically qualify Vendors through questionnaires or formal audits, often conducted by internal staff or consultant auditors. For smaller companies with limited internal resources, third-party consultants are especially common. The result is slow, costly, and redundant: every Sponsor runs essentially the same process on the same set of Vendors, creating a compounding burden that grows as Vendors take on more clients. 

Diligent entered the market as a specialized qualification consultant, qualifying Vendors on behalf of Sponsor clients through proprietary Qualification Questionnaires and Diligent-conducted audits. Over time, a clear pattern emerged: performing a full qualification audit of a lab or CRO for one client, only to repeat the exact same process for the next, was an unsustainable model. Diligent centralized this qualification process. Rigorous due diligence is performed once, with full Vendor consent, and the results are made available to all qualifying Sponsors. 

How we deliver

The result

We've become the industry's trusted, independent qualification organization. Instead of waiting months to even get on a Vendor's audit calendar, Sponsors can request and receive questionnaires or a full qualification audit report in days. Vendors undergo a Diligent qualification once, and then can share that data with other clients. All sides benefit from shortened timelines, cost savings, and a rigorous compliance process built in step with regulatory requirements.

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 a Diligent qualification and share the results with your other clients. 

For the industry

A stronger compliance standard

A rigorous, risk-based qualification model aligned with the standards regulators expect.

The difference

A new model. Full regulatory confidence.

There is nothing rogue from a regulatory perspective here. ICH E6(R3) requires risk-based qualification, and Diligent makes it happen faster and with far less redundancy. Sponsors relying on independent 3rd parties to qualify vendors is not new. What is new is the model. Rather than operating as a traditional audit firm — producing one-off reports for one client at a time — Diligent operates a centralized platform where qualification work is performed once and made reusable, with full vendor consent.

Traditional Model

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Each Sponsor commissions their own qualification of the same Vendor — this same work is repeated

Months to get on a Vendor’s audit calendar 

Every Sponsor pays full market rates for work that's already been done elsewhere 

A one-off audit firm relationship 

Diligent Model

Centralized, reusable, consented

Qualification is performed once and made accessible to all qualifying Sponsors 

Qualification audits and questionnaires available in just days 

60% average cost savings on qualification 

A expert-led, independent qualification organization

The model works because it's built on trust. Sponsors never see other Sponsors' data. Vendors never see other Vendors' data. Every release requires explicit Vendor consent — and Diligent remains fully independent throughout. 

Our regulatory experts and qualified auditors actively track guidance across ICH, FDA, and EMA, so clients stay ahead of evolving requirements without having to monitor every update themselves. 

Benefits

Why vendors join the Accelerator Tier.

Vendor strategy 

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

Vendor qualification 

Assess Vendor capabilities, quality systems, and compliance history through Diligent's 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 Diligent gets qualification done faster, with the compliance rigor your trials demand.

Book a demo