How a commercial-stage biopharmaceutical company saved 150+ weeks on Vendor qualification

About the Client

A commercial-stage pharmaceutical company specializing in treatments for rare neurological diseases, with multiple programs in active trials. 

The Challenge

As a small quality team running active trials, qualifying clinical Vendors was a constant pressure. With multiple programs advancing simultaneously and no budget to add headcount, every hour spent on Vendor qualification was an hour pulled from higher-priority work. 

The traditional model of qualification made that problem worse. Qualification questionnaires needed to be updated to reflect current regulatory requirements, making each questionnaire a time-consuming, manual project. Further, performing Vendor audits meant waiting months for scheduling. With multiple trials moving forward on fixed timelines, they needed a way to qualify Vendors faster. 

The Solution: Diligent Pharma  

The company partnered with Diligent Pharma to transform their Vendor qualification approach:

• Rapid RFI Collection: Their team accessed completed qualification questionnaires from Diligent's platform to evaluate Vendor capabilities, with questionnaires released in days rather than weeks or months. 

• Questionnaire Builder: Using Diligent's questionnaire builder, the team was able to create, manage, and send Vendor qualification questionnaires at scale, saving time and effort spent on spreadsheets and manual formatting.

• Immediate Access to Existing Audits: Instead of scheduling new audits and waiting months, they accessed readily available audit reports from Diligent's VendorBase for Vendors already qualified by Diligent's expert auditors.

• Global Team of Expert Auditors: By leveraging Diligent's global network of auditors, the team were able to request new audits without straining the team's resources, allowing them to reallocate quality resources to more important tasks.

The Results  

In their four-year relationship with Diligent, the company achieved: 

• 7-day average Vendor questionnaire turnaround time compared to a 4-week industry average.

• 150+ weeks saved on the qualification questionnaire process compared to the traditional method.

• 30+ unique Vendors qualified over their 4 year relationship with Diligent.

• $120,000 saved through access to existing reports.