Diligent Pharma is Now Supporting GenVault with a Streamlined Approach to Vendor Qualification
Through a rigorous two-day assessment, Diligent Pharma has proactively, and comprehensively, qualified GenVault, evaluating their capabilities and services against the highest standards of global regulatory requirements and industry best practices. Diligent now stores GenVault’s report (and RFI data) in their secure platform for release to interested parties, enabling clients to avoid duplicating the same qualification process and onboard GenVault more quickly.
GenVault is one of the most secure, comprehensive commercial biorepositories in the US. Located in West Deptford, NJ, it shares a half-million square foot purpose-built campus with its sister facility DocuVault, which opened in 2002 as the region’s only facility specifically designed and built for records management. GenVault stores and transports large collections of biological materials, laboratory chemicals, infectious and non-infectious materials, and high-value equipment for academic research institutes, pharma companies, biotech, and government.
As a leader in the industry, GenVault is not only focused on innovating in the biorepository space, they are also focused on innovating processes and tools that will enable the industry to work together more efficiently. Working with Diligent is a validation of that mindset.
Why This Relationship Matters
By adopting Diligent as the new best practice for vendor qualification, both GenVault and Diligent are signaling to the industry that the current vendor qualification process is slow and inefficient, and simply not good enough. With the entire industry being hyper-focused on speeding up clinical trials, settling for the status quo will only compound the current industry dysfunction and sluggishness in the vendor qualification process.
Traditionally, qualifying a vendor is both time-consuming and costly, with sponsors typically spending over $25,000 and taking more than 100 days to complete the process. However, by leveraging Diligent’s FDA-accepted model, sponsors can access GenVault’s Qualification Package immediately, drastically reducing costs and onboarding time.
Qualifying a provider traditionally takes over $25,000 and 100+ days. With Diligent, you can access the qualification package immediately.
In a recent webinar, GenVault shared why they chose the Diligent model as their preferred process for vendor qualification:
“Before, our audit process was tedious and time-consuming, requiring extensive coordination. With 20+ audits annually, our capacity to onboard new clients was constrained, potentially missing the window for new engagement and putting our revenue at risk. Collaborating with Diligent streamlines our onboarding process, addresses contract delays, and ensures consistent auditing standards across the market segments we serve.”
Imagine the boost in capacity and efficiency when GenVault, and other vendors, only have to undergo qualification once a year through Diligent Pharma.
What’s Included in the GenVault Qualification Package?
The GenVault Qualification Package, available through Diligent Pharma’s secure platform, includes:
- A comprehensive Qualification Audit Report covering the Genvault organization and complete suite of services: Bio Inventory Support, Local Transport Services, and Storage Solutions
- Observations and current status of CAPA commitments
- Auditor’s credentials
- Core Qualification Questionnaire (RFI)
GenVault services areas audited: Core Capabilities, Bio Inventory Support, Local Transport Services, and Storage Solutions.
Key Benefits for Trial Sponsors
By accessing the GenVault Qualification Package, clients can enjoy:
- Higher Compliance: Ensuring adherence to global regulations.
- Faster Vendor Onboarding: Streamlining the qualification process with pre-qualified data.
- Greater Efficiency and Cost Savings: Reducing the financial and time burden of vendor qualification.
- Shorter Clinical Start-Up Times: Accelerating your clinical trials.
A Trusted and Accepted Model
Diligent Pharma’s qualification model is not only trusted by top ten pharma companies, but also accepted by the FDA. Each auditor on the Diligent team has over 10 years of GxP experience, ensuring the highest quality and reliability in the audit process. Moreover, the FDA has inspected Diligent’s clients with zero incidents related to the reuse of centralized qualification data, reinforcing the credibility and robustness of this approach.
Access the Qualification Package Today
Ready to streamline your vendor qualification process? Access the GenVault Qualification Package now and experience the benefits of this innovative approach.
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.