Frequently Asked Questions by Trial Sponsors
For FAQs by service and technology providers, please click here
Do trial sponsors using Diligent have to provide a vendor to be qualified or can Diligent Pharma provide a list of vendors they’ve qualified?
As a sponsor, you can see information for providers who have already been qualified by Diligent and you may also request any new providers to be qualified by Diligent.
How often do you perform assessments onsite vs questionnaire or virtual?
During the COVID-19 pandemic, almost all of our Vendor Qualification Assessments (VQAs) were conducted remotely. However, in the last 6 months, sponsors & providers have been requesting and allowing onsite VQAs. At late 2022 approximately 20% of our VQAs are being planned as onsite, face to face assessments. We can do whatever our pharma client requests as long as the provider allows onsite visitors.
How does the qualification system account for differing quality standards or aspects across various sponsors?
Diligent has the flexibility to meet the needs of each of our Client’s Quality Management System (QMS) expectations regarding Vendor Qualification. Some clients rely only on self-reported answers to Requests for Information (RFIs), while others rely on Vendor Qualification Assessment (VQA) Reports based on an independent review. And some rely on both documents to demonstrate vendor qualification. Every document is version controlled and date stamped to reflect the date the content was updated by the Provider. If the existing material is not “fresh” enough to satisfy the QMS requirements, we will act on behalf of the sponsor to ensure that the RFI or VQA is updated or redone to a current date that is acceptable.
Who benefits most by us using the Diligent Qualification Platform – trial sponsors or Service Providers?
See more here: Benefits for Trials Sponsors
If we use the Diligent platform, can we ask a question of our own that is not in the standard Diligent Request for Information (RFI) template?
Yes, you can add custom questions in your RFI request on the Diligent Platform. Your custom questions and answers are not shared with other Sponsors but are segregated for your company only. This allows you to be specific, if necessary, about your clinical development program and the technologies you need.
How widely recognized are the WCG Avoca standards that Diligent RFIs are based on?
The WCG Avoca standards are industry-leading standards, recognized globally. There are over 200 member companies within the Avoca Quality Consortium and its advisory board ensures the tools they develop meet the needs of the broadest group of members.
If my company procures a Vendor Qualification Assessment (VQA) report that is in the library, do we see CAPAs and the progress/action to resolve those?
Yes, the CAPA commitments are included in the VQA Report. When an existing VQA is requested, we give the provider an opportunity to add an appendix document that provides the current status of CAPA implementation.
Does Diligent have ability to audit in any geography?
We have auditors in every geography and can support a VQA in any country around the globe.
How are costs charged to sponsors for on-site vendor assessments?
These are scoped separately on a case by case basis due to the variability involved.
How long does it typically take to schedule a face to face provider assessment?
It depends on the provider’s availability as well as our auditors’ availability. Diligent requires 3 weeks advance notice to schedule an assessment, but obviously the more advance notice the better chance for success.
Are contracts drawn up between the sponsor, Diligent and service provider on an as needed basis to conduct an assessment?
Yes, a new SOW will be developed for any assessment requests between Diligent and sponsor.
How does the pricing for sponsors work?
As a sponsor, you would sign up for one-year or 2-year subscription to the platform. You only need one subscription for your organization as it can be shared across all your teams.
Referencing a central database for vendor information is only valid at the time of data collection. When vendor key personnel and SOPs change, is another qualification required?
Every request for information (RFI) from a sponsor is sent to the relevant provider. That provider has the opportunity to refresh details before releasing it to you. Rather than having to recreate all the RFI content, they can focus on the areas that have changed since their previous update. This enables a resource efficient methodology for issuing the latest information.
How can you evaluate “expertise” in a capacity more than only the capability to execute? We have seen many vendors that say that they can do something but do not always know how to do it.
We look for the presence of controls around a stated capability. This evaluation takes the form of a review of active SOPs that describe the provider’s processes. We also review a sample of staff members’ job descriptions, CVs & training records to confirm that the provider can demonstrate that they have qualified staff. We also review the HR staffing approach and review their staff turnover rate. If the turnover rate is high, we highlight that as an indicator that should be carefully considered by sponsors. We do not do a capacity analysis to understand whether they have enough qualified staff to perform a particular program.
How long can I consider a provider qualification effectively valid?
Each pharma or biotech company has different quality management system (QMS) requirements. Some require “re-qualification of vendors” every 2-3 years. Others require one qualification and then move the vendor into a vendor audit program that evaluates them every 2-3 years. We can support whatever frequency is required by your QMS.
Are there plans to add standards for more areas on the platform?
Yes – we are continuously adding new RFI areas to our platform. In 2022 we added Pharmacovigilance services. Upcoming standards include Investigational and Medicinal Product Management, Investigator Site Qualification, Mobile Biomarker Sensors and Mobile Respiratory Sensors.
What is the standard timing for vendor qualification?
We try to accommodate the timing needs of our clients based on their clinical development program needs. The shortest turnaround times for a new vendor qualification assessment (VQA) to get to a draft report has been 30 days. However, most common timing for new VQAs has been 2-4 months. This timing is highly dependent on the vendor’s availability to host the VQA. Some have been significantly longer due to the vendor’s schedule.
On the flip side, existing VQA Reports have been provided to requesting sponsors in 1-2 days. This is obviously a huge time and resource saver for both you and provider.
After we review a set of RFI answers, if we have more questions, does the original RFI get updated with additional questions and responses, so other sponsors can benefit too?
This will not happen as a function of the platform, however we review new or additional questions we receive from sponsors on a regular basis to determine if they should be included in future updates to the RFI template.
Can we request to see RFIs for other providers if we see them on the Diligent platform?
Yes, once your organization subscribes to the Diligent platform, you can request RFIs from any of the participating providers. Additionally, we can approach and onboard new providers for you as you need.
Is Diligent an Audited Resource?
Diligent has been audited by several Sponsor clients. These are conducted on an as-needed basis depending on the Sponsor and their service provider SOPs and/or qualifications.
Does Diligent carry out in-study audits?
Our primary focus is on vendor qualifications, but we do conduct in-study audits for our clients on request. Our auditors are highly experienced and capable of conducting such audits as well as our vendor qualification assessments (VQAs).
When a sponsor is audited, do they reach out to Diligent for information or does the actual vendor do that?
We provide vendor qualification assessment (VQA) reports that demonstrate that you adequately “qualified” the vendor. This can be accompanied with the VQA Certificate that provides an overview of the services that were in the scope of the VQA for showing to the regulatory inspector.
Can the Diligent auditors cover both process and technical/systems (e.g CFR 21 part 11) as well as functional expertise? e.g. programming or statistics
Yes, our Diligent auditors can cover all aspects of a qualification assessment.
How are non-conformities handled? Are they funneled through you (DEV, Change Notification etc.)?
You would receive the first draft of the vendor qualification assessment (VQA) report as soon as possible from our auditors for your review. Our auditors are trained to report potential “critical findings” immediately and we rapidly schedule a “notification to management” meeting to quickly highlight the potential critical finding. You would handle this in your own company, based on your individual quality management system (QMS) requirements.
What are your comments on the qualification of small, new niche suppliers who do not have official documented processes (i.e. SOPs, WPs) that we would see with some larger, more established suppliers?
We recommend you take a risk-based approach based on the intended use of data and service outcomes (e.g. exploratory data etc.) as well as your options and alternatives to each vendor. Enhanced vendor oversight and risk mitigations (together with CAPA observation completion) can help to close any gaps and mitigate risks, but it may not be enough if the vendor has no quality management system (QMS) and can’t comply with good clinical practices (GCPs).
If you have other questions about the Diligent Platform and how it could accelerate your trials and help your company save time and resources with provider qualifications, please email firstname.lastname@example.org
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