Identifying Risks for Outsourced Services

– A Novel Approach to Provider Qualification –

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Questions and Answers:

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 WCG Avoca standards? And how are suggestions for new standards brought forward at Avoca Quality Consortium (AQC)?

Both are great questions. Suggestions are brought forward in a couple of different ways, primarily through the leadership advisory board. A group of people, who are passionate about the area and change, bring forward their needs. That creates a list of interests that is sent out to our members. We do what’s called a pulse survey every year to really help us understand current interests. Given how widely recognized the standards are – we have over 200 member companies within the consortium – we want to make sure that the tools we are developing meet the needs of the broadest group of members.

Do Providers have control/autonomy on what is shared on the Diligent platform?

Providers can approve or reject any request for information from a Sponsor. They also have the ability to update any of their details before releasing a Request for Information (RFI) or a Vendor Qualification Assessment (VQA) report to a requesting Sponsor.

Who benefits most by us using the Diligent Qualification Platform – Sponsors or Service Providers?

Both sponsors and service providers benefit but in different ways. If you think about it, it’s very challenging to be a provider these days: the level of outsourcing is increasing significantly and having to respond to so many requests for information and fill out all those qualification questionnaires is time consuming. That’s one aspect of the challenge that Diligent addresses for providers because they only have to fill the questionnaire once, and then sponsors can access that information. I think the harder part for providers is having to host so many vendor qualification assessments because it’s not just a sponsor asking for information; there is a lot of preparation and there are team members that have to be assembled.

I remember a client we worked with estimated that they make 300 visits a year. You can imagine the expense for providers. The provider community benefits significantly from the centralization of the qualification practices. For sponsors, it’s about speed, it’s about efficiencies around cost, but it’s also about risk mitigation. It’s hard to say who benefits most because they benefit in different ways.

As a provider, do we have the ability to approve release of Request for Information (RFI) or Vendor Qualification Assessment (VQA) report prior to Diligent sending to sponsor?

Yes, control of the release of both RFI’s and VQA’s sits with the Provider. Nothing is released without the Providers’ approval/release.

How many Vendor Qualification Assessments (VQAs) have you conducted? Do you have ability to audit in any geography?

66 VQAs have been completed and reports have been approved. 7 VQAs are currently in process, as at October 2022. We have Auditors in every geography and can support a VQA in any country around the globe.

Referencing a central database for vendor information is only valid during 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 the details before releasing it to the Sponsor. 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 getting out the latest information.

How does the qualification system or process 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 Requests for Information (RFIs) while others rely on Vendor Qualification Assessment (VQA) Reports. And some rely on both documents to demonstrate vendor qualifications. 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.

You have a new vendor that has passed all qualification steps and an audit. You still have a gut feeling this vendor will prove to be a bad fit for your company. Is it better to go with your gut or the results of the qualification? Is Diligent effectively an extension of a sponsor’s organization qualification function to handle end to end qualification activities?

I think there are three key dimensions to this. The first one is the qualitative component. Thinking of contracting and third-party oversight, and Diligent being an extension of the sponsor, the sponsor is ultimately accountable. But I think Diligent qualification or use of third parties for qualification services can enable two things for the sponsor:

A) if the sponsor has a quality management system that requires a qualification, or
B) Diligent providing the capability that could enable compliance to the sponsor’s internal Quality Management System (QMS) around vendor qualification.

The second dimension is that the output of the Diligent qualification could and should inform your oversight. It should inform your risk management and your compliance management – as well as your performance management – if there are things that come out from a qualification that need more scrutiny, issue management or risk management.

And the third one is through audits. If you have a gut feeling as you look at the qualification output, at the services to be provided, even the quantification and oversight and management of risks, you could decide that you’re going to accelerate an in-process audit. This would give you a level of reassurance, or validate the nature of your concern around performance and/or quality, compliance or integrity, making sure that you get the output of that information earlier rather than later.

To add one more thing, another part of it is optionality. How many other vendors or providers can provide the capabilities for the services you need? Is this the only lab in the world, or the only e-clinical provider or decentralized clinical trial (DCT) resource? You may not have a lot of choices, which means you’re going to have to make a risk-based decision and enhance your oversight to enable satisfactory performance and outcomes. If you have alternatives, perhaps that can inform whether you move forward. But maybe you have no choice but to pursue that particular vendor again, with represented investments and risk management.
I think it’s not a one-size-fits-all, there are lots of inputs. But I think you can get satisfactory outcomes if you look at it through the context of oversight, risk management and optionality.

How can you evaluate “expertise” in a capacity more than only the capability to execute? We have seen many CROs that say that they can do something but 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 a sufficient number of qualified staff to perform a particular Program.

Based on your experience, how long is a qualification effectively valid? Knowing that we are in a very dynamic world and systems/people/processes change quickly (e.g. systems upgrades, acquisitions, etc.).

Each of Sponsor Clients have 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.

Patient engagement (i.e. PROs/patient interviews, etc.) has become an important part of clinical trials – are there plans on adding standards for this area?

Yes – WCG Avoca will bring forward patient engagement standards as part of the Leadership Advisory Board to determine it’s prioritization for development. If your organization is a member of the AQC, we recommend that you attend the LAB to get your input counted if this is an area of interest for your organization.

I realize this seminar aims toward Clinical Trials. What about Commercial Vendors? Some of the same Vendors used for Clinical are also continued to Commercial Products?

I think many aspects of the “core” Request for Information (RFI)/Avoca Quality Consortium (AQC) are relevant to the commercial space. Similarly, if a vendor provides both clinical trial and commercial services (eg. a lab that performs commercial laboratory diagnostic testing and clinical trial laboratory testing), the category RFI “technical” content can also be relevant / transferable (eg. laboratory assay validation). I’m not a commercial expert, however I suspect you many need to augment your qualification scope with some domain commercial content as well.

Would you share your slides so that we could share with our colleagues?

Yes, you can access them at the top of this webpage.

Does the sponsor have to provide a vendor to be qualified or can Diligent Pharma provide a list of vendors they’ve qualified?

The Sponsor can view providers who have been qualified by Diligent and they may also request new providers to be qualified by Diligent.

What are your thoughts on the assessment/qualification of small/new niche suppliers who do not have official documented processes (i.e. SOPs, WPs) as we would see with some larger/more established suppliers?

I think you have to take a risk-based approach based on intended use of data and service outcomes (eg. exploratory data etc.) and vendor options/alternatives. As per the webinar, enhanced vendor oversight and risk mitigations (together with CAPA observation completion) can help to close the gaps and mitigate risks, however it may not be enough if the vendor has no Quality Management System (QMS) and can’t comply with Good Clinical Practices (GCPs).

What is the standard timing for supplier qualification – prior to award/contracting, or in parallel (and potentially after contracting)? It would be difficult to qualify every provider being considered during an Request for Proposal (RFP) process. It makes sense to prequalify, when possible, but often the lead-in time does not allow for prequalification.

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/Provider’s availability to host the VQA. Some have been significantly longer due to the Vendor/Provider’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 Sponsor and Provider.

Are you an Audited Resource?

Our primary focus is on Vendor Qualifications, but we do conduct In-Study Audits for our Clients upon request. Our Auditors are highly experienced and capable of conducting Audits as well as our primary focus on Vendor Qualification Assessments (VQAs).

When a Sponsor is audited, do they reach out to you for information or the Actual Vendor?

We provide Vendor Qualification Assessment (VQA) reports that demonstrate that the Sponsor 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.

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 the current time 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 are non-conformities handled? Are they funneled through you (DEV, Change Notification etc.)?

Sponsors receive the first draft of the Vendor Qualification Assessment (VQA) Report as soon as possible from our Auditors for their 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. Each Sponsor has their individual Quality Management System (QMS) requirements on how they handle that within their company.

In the context of a clinical trial, do we need to qualify local laboratories around the patient’s location when they are intended to be used?

Great question, it depends if the local lab is affiliated/assessed as part of investigation site/hospital qualification or if it’s a standalone local lab. Additionally, you need to determine if they are actually performing laboratory testing/sample analysis or only sample collection and phlebotomy services. In many cases clinical trial “local labs” fall into one of the two categories above and require limited qualification.