How we qualify

Trial Sponsors are responsible for ensuring that the clinical service Providers they collaborate with possess the necessary qualifications and adhere to GCP/GCLP requirements. Leveraging our meticulous assessment process, regulatory acumen, and industry expertise, we empower pharma and biotech companies to make informed determinations with unwavering confidence.

Proven process

Each Provider undergoes a rigorous, two-day assessment led by expert auditors who utilize assessment standards in accordance with the latest GCP/GCLP guidance, incorporating relevant local and global requirements and industry best practices. If any regulations hold authority over a Provider, and if they directly impact the risk assumed by a Sponsor engaging with that Provider, then we check it.

Qualification standards

  • Keeping up with regulations and navigating the qualification process is challenging, especially when it comes to new and emerging clinical technologies. With assessment standards drawn from the latest regulatory guidelines, Diligent Pharma operates under the ICH Vendor Risk Management Framework, bringing peace of mind to every evaluation.

    Click here to learn more about our Qualification Standards and Service Areas.

Unmatched expertise

  • Diligent employs industry-veteran auditors with over ten years of GCP/GCLP expertise to benchmark provider capability and tailor solutions to Sponsor requirements. The team, including leaders from both Sponsor and Provider sides, from diverse clinical and quality applications, goes beyond traditional approaches, offering ongoing support and a long-term, data-centric strategy.

The Diligent model

How does Diligent work?

Our team qualifies clinical trial technology and service Providers using a rigorous, standardized approach. This effort generates a Qualification Package – the audit report and complete Qualification Questionnaires (RFIs) – that Providers can manage on our secure platform and share with interested trial sponsors. Sponsors can approach a provider, make a confidential request for their qualification package, and upon Provider approval will receive the data needed to qualify the Provider with confidence.

Is using centralized qualification data a credible and acceptable qualification method?

ICH Q9, ICH Q10, and ICH E6 leave the vendor qualification method up to Sponsors, and the industry has long relied on independent audits to qualify the same Providers. Diligent is simply centralizing qualification data for secure reuse, removing the redundancy of multiple Sponsors completing the same qualification assessments. Our FDA-accepted qualification model eliminates the need for separate auditors, styles, and findings through the secure reuse of centralized qualification data. It’s up to date and includes all the information Sponsors require to qualify Providers quickly and compliantly.

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.