Diligent Success Stories
How our subscribers use Diligent to accelerate provider qualification and manage risks effectively
The Diligent Qualification Platform helps clinical trial sponsors and CROs to gather the information they need quickly to assess and manage risks to clinical trials from outsourced services.
On this page we give some real-life examples of how clinical trial sponsors have benefitted by using Diligent, covering a range of challenges in the qualification of service providers for clinical research including:
• Providing capacity relief
• Expedited vendor qualification
• Using a global auditor network
• Dealing with a process backlog
• Making a study compliant with regulations and back on track with clinical development milestones
• Effective and manageable workload distribution
• Experience/knowledge offering
• Increasing flexibility in working across business units/companies
Diligent supports effective and timely CRO selection for top 10 pharma
Provider qualification backlog eliminated by using Diligent’s global network of auditors
How a top 15 pharma company saved time with GCLP qualification
Over 10 Vendor Qualification Audits (VQAs) across multiple regions with translations for a top 10 pharma
Diligent effectively qualified hundreds of providers for two Sponsors in just one year
Reducing risk by qualifying e-technologies/cloud-based computer data systems
Diligent supports effective and timely CRO selection for top 10 pharma
Allowing internal QA teams to focus on high priority needs
Challenge
Decreasing the QA burden of managing qualification efforts and priorities internally for a top 10 pharma company. Diligent conducted customized assessments that included risk scoring for key CROs to inform selection for pivotal clinical studies.
Solution
- Conducted focus groups with functional SMEs to prioritize critical risk areas to incorporate in RFI Risk Scoring
- Provided experience and knowledge to guide qualification activities for sponsor selected providers
- Provided CRO customized assessments in an expedited timeframe (within 14 days)
Impact
- Effective resource allocation: the sponsor was able to focus internal QA resources on high priority needs
- Risk Scoring significantly reduced staff review time
- Timely adaptability and prompt delivery allowed the sponsor to make informed decisions about CRO selection for pivotal clinical trials
Challenge
The sponsor was faced with both a significant backlog of provider qualifications and a need for skilled competency and experience in qualification processes and requirements. Diligent was able to address these challenges and deliver multiple Vendor Qualification Assessments (VQAs) in record time.
Solution
- Conducted over 25 VQAs in year 1 of their subscription (delivered on average 2 VQAs/month)
- Provided experience and knowledge to guide qualification activities for sponsor selected providers
Impact
- High volume of VQAs conducted within a year eliminated the provider qualification backlog for this sponsor
Provider qualification backlog eliminated by using Diligent’s global network of auditors
Multiple VQAs delivered in record time
How a top 15 pharma company saved time with GCLP qualification
Accessing the Diligent VQA Library for provider qualification
Challenge
Diligent addressed the sponsor’s specific need for assistance in finding and qualifying laboratory providers as their internal capacity to meet volume needs was insufficient. It was also important to the top 15 pharma company that all providers considered were following Good Clinical Laboratory Practice (GCLP). This request was easily covered as adhering to GCLP is just one of the hundreds of screening questions the Diligent Qualification Platform provides for vendors.
Solution
- Conducted new Vendor Qualification Assessments (VQAs) with Laboratory vendors on behalf of sponsor
- Provided existing final VQA reports to sponsor from the Diligent VQA Library eliminating the need to conduct a new audit.
Impact
- Delivery of an existing final VQA report saved time, improved resource utilization, and provided financial savings for both the Sponsor and Provider
Challenge
Addressing the lack of global auditor resources for a top 10 pharma company. Diligent supported the company’s qualification needs across multiple business units. Audits were prioritized and scheduled quickly to meet the time demands.
Solution
- Conducted more than 10 Vendor Qualification Assessments (VQAs) across multiple countries (including Foreign Document Translations) in first year of the company’s subscription to Diligent
Impact
- Provided capacity relief to the sponsor for their vendor qualification needs
- Provided multiple options inclusive of their corporate and affiliate needs across different regions and business units
Over 10 Vendor Qualification Audits (VQAs) across multiple regions with translations for a top 10 pharma
Staff unburdened by provider qualification efforts
Diligent effectively qualified hundreds of providers for two Sponsors in just one year
Hundreds of RFIs delivered successfully
Challenge
Diligent addressed sponsors’ need to pre-qualify a significant backlog of provider RFIs.
Solution
- Diligent delivered responses for over 100 Request for Information (RFIs) questionnaires for the first sponsor in 2 years of their subscription (on average 5 RFIs/month)
- Diligent delivered over 100 RFIs in year 1 year for the second sponsor (averaging 8 RFIs/month)
Impact
- Diligent successfully provided capacity relief during sponsor reorganization efforts and transition of staff with no interruption of delivery
Challenge
Diligent addressed specific sponsor qualification needs for providers with capabilities in new Electronic Technologies/Cloud-based Computer Data Systems.
Solution
- Scheduled or conducted Vendor Qualification Assessments (VQAs) with Electronic Technology providers in year 1 of their subscription
- Provided final reports from existing VQAs, eliminating the need for comprehensive new VQAs
Impact
- Provided an expanded view of new providers to support e-Technologies
- Delivering existing final VQA reports saved time, improved resource utilization, and provided financial savings for both the Sponsor and Provider
Reducing risk by qualifying e-technologies/cloud-based computer data systems
Several VQAs provided in just one year of subscription
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