Qualification standards & service areas

Diligent auditors utilize assessment standards in accordance with the latest GCP/GCLP guidance, incorporating relevant local and global requirements and industry-leading best practices.

Core standards

Every qualification assesses Providers against a set of core standards to confirm the tenets of regulatory compliance and provider capability.

GCP/GCLP service categories

We use separate technical standards based on a provider’s unique service area, with expertise spanning thirty-one categories across the clinical trial ecosystem.

Confidence in every evaluation

Our independent, expert-led audits enable Sponsors to qualify Provider capabilities, infrastructure, and processes, verifying alignment with global regulatory requirements, GCP/GCLP guidelines, and the ICH Vendor Risk Management Framework for qualification.

Innovation trusted by industry leaders

Several of the top ten pharma and biotech companies, with some of the most stringent quality standards, are Diligent clients leveraging our FDA-accepted audit model. Our proven process, qualification standards, and unmatched expertise consistently exceed expectations.

“This model has exceeded our expectations.We very much like the consistent assessment criteria…

… [which] helps us feel confident in the scope of the audit. When I do the math and calculate the average cost per audit, it comes out to be lower than what I would spend on a standard, routine audit.​

The readily available VQAs [audit reports] and RFIs have shortened the time to qualification.”

“Eli Lilly & Co. (Lilly) is a proponent of Diligent Pharma’s centralized model and the organization’s efforts to drive efficiency in the qualifications of vendors.

Lilly is encouraged about the future of Diligent, as more companies, including large CROs and technology providers, begin to participate in Diligent’s centralized model to reduce the collective resource burden of vendor qualification across the industry.”

Questions? Let’s chat.

Schedule a one-on-one with our team to learn more about how Diligent can support your unique qualification and risk management needs.