Frequently Asked Questions

Diligent Pharma is a quality and risk management organization with a central platform for driving speed, efficiency, and compliance clinical vendor qualification.

Diligent Pharma takes an objective, rigorous, and central approach to vendor qualification and audit modernization. We help Sponsors and providers eliminate bottlenecks and redundant practices, expedite clinical trial start-up times, and ensure compliance in the process. Our mission is to drive change and transformation in the clinical trial process so treatments can get to patients faster.

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

ICH E6(R3) states that Sponsors are responsible for assessing the suitability of and selecting the service Provider/Vendor to ensure that they can adequately undertake the activities transferred to them. Our independent, expert-led audits enable sponsors to qualify Vendor capabilities, infrastructure, and processes; verifying alignment with global regulatory requirements and GCP/GCLP guidelines.

Vendors retain complete control over their audit reports and RFIs and must approve their release whenever a Sponsor submits a request. Only the Vendor’s name, service areas, and data available for request are shown on their profile. Sponsors cannot see who else has requested a Vendor’s data.

ICH Q9, ICH Q10, and ICH E6(R3) leave the qualification method up to trial Sponsors, and the industry has long relied on independent auditors to qualify the same Vendors. Diligent is simply allowing multiple Sponsors to benefit from a single qualification, eliminating the redundancy of every Sponsor conducting similar qualification assessments.

Each auditor on our team has 10+ years of GCP or GCLP experience and the appropriate technical expertise. Several top ten pharma companies, with some of the most stringent quality standards, are current Diligent clients, leveraging our FDA-accepted cooperative audit model. Our processes and detailed information exceed their internal expectations for vendor qualification.

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.

The FDA has inspected our clients with zero incidents related to using Diligent’s platform and existing audit reports. The model holds up during the NDA/BLA process, as well.

Yes, CAPA commitments are included in every report where applicable. Our auditor also reviews them for effectiveness in addressing each identified risk. Providers are also allowed to provide an update on the status of CAPA implementation when releasing their reports.

RFIs are always current and are updated upon release by the Vendor. Diligent requalifies most Vendors every year to create fresh audit reports.

With an annual subscription to Diligent, we can serve as an extension of your team and conduct additional audits to cover any bespoke areas of interest.

Yes, this service is included in our subscription offering.