May 6, 2024

Revolutionizing Clinical Trial Service Provider Qualification

A Process Efficiency that Reduces Qualification Burden and Accelerates Time to Revenue in an Increasingly Competitive Landscape


Chris Casazza

Chief Commercial Officer, Diligent Pharma

Andrew Lee

Executive Director, GenVault

Nicos Zittis

Senior Manager, Vendor & Relationship Management, Regeneron

Peter Haessig

Director, Client Partnerships, Diligent Pharma

Jay Turpen

Senior Quality Advisor, Diligent Pharma

Webinar transcript

Chris Casazza: All right, good afternoon. Good morning, everyone. Welcome to today’s webinar. My name is Chris Cazazza. I’m the Chief Commercial Officer at Diligent Pharma.

I will be your host for today’s webinar and I’ll also be leading us through several parts of our presentation today. You will hear from a number of colleagues of mine at Diligent Pharma today as well as a couple of our clients who will talk about why they’re working with Diligent and their experience with us. Each speaker will introduce themselves more formally at the start of their presentation. And thank you in advance to each speaker for your contribution to the webinar.

The title of our webinar today is Revolutionizing Clinical Trial Service Provider Qualification, A Process Efficiency That Reduces Qualification Burden and Accelerates Time to Contract in an Increasingly Competitive Landscape.

We’re excited about the mix of attendees joining our webinar today, which includes both sponsors and providers of all sizes across the industry. So as I mentioned, we are going to talk about clinical trial service provider qualification.

It is not the most sexy topic in our industry, but it is a regulatory imperative and it’s important for us all as we’re working to get into relationships with both sponsors and providers. I want to start out by asking a polling question of the audience.

It’s in front of you on the screen right now. How would you characterize the strain that the current vendor qualification process puts on your internal teams?

We’ll leave this up for a moment, and then we’ll share the results in a few seconds. Right. The answers are populating here.
Looks like a fair amount of strain from threes, fours and fives that we’re seeing on the screen. It seems like there’s a significant amount of impact on your internal teams. That is good grounding to kick us off in the conversation is probably quite relevant based on the data that we’re seeing here. Thank you for that.

Let me take you through vendor qualification from the perspective that we sit in that diligent pharma.

The process has been the same process for decades. Every sponsor is going through the same qualification steps with every service provider. And providers are completing the same task over and over again. The process is duplicative and inefficient, and quite frankly, we’re settling for this inefficiency.

This is causing some burden on the providers, right? It’s taking months to schedule and complete these tasks, putting a heavy burden on resources and with different auditors having different styles and approaches, it’s creating inconsistent reports and findings and it’s slowing the process of getting to contract quickly with sponsors, impacting providers’ ability to generate revenue quickly and quite honestly putting revenue at risk.

In talking with our sponsor clients, the feedback that we’re getting in the current process is that it’s causing delays in study start-up time. It’s having a high-cost burden on their team. There’s a lot of variability in quality and inconsistency in the data that they’re capturing for providers.

They’re set up in silos in terms of how they’re evaluating vendors. It’s introducing risk and it’s slowing the onboarding process for providers, inhibiting innovation and discovery of providers at the same time.

But the dysfunction is not just with the sponsors and the providers in the industry, the dysfunction is also seen from the auditors in the process and in the end the negative impact is on the patients.

With a delay in start up time with trials, it means that treatments are getting to patients less quickly and it’s having a negative impact on the patients as a result.

So let’s talk about the cost impact of vendor qualification on the industry. We’ve got some pretty compelling numbers that we’re sharing on this screen, 400,000 qualification events per year across the industry with a cost of about $4.5 billion on the industry. We talked a lot about the burden sponsors and providers are facing in terms of the slowness in the process, but it’s also creating a cost burden as well.

Let’s ask you another question.
Rread this question please and based on your perspective answer what your estimate is of the total cost burden associated with hosting a single qualification audit, if you’re a provider. And for sponsors, estimate the total cost associated with conducting a single qualification audit. We’ll share the results in a moment.

Right, the data is populating. It looks like there’s a strong feeling that the cost is 10 to about $20,000. The impact from that both sponsors and providers are facing in the qualification process.
It seems to be a convergence of data around the 10 to 20,000 mark. Let’s share some data that we’ve captured over time from qualitative conversations with sponsors and providers across the industry, but also grounded in a quantitative market research study that was conducted a number of years ago.

The data suggests that sponsors have an impact of about 25 to $35,000 for conducting a single qualification audit. And that burden on providers in terms of hosting that audit is about a 30 to $40,000 impact.

That is our assessment and feedback overtime. We are going to refresh that data and produce new data here shortly. Diligent Pharma is partnering with the Tufts Center for the Study of Drug Development to conduct another quantitative research study on the impact of vendor qualification across the industry.

We will quantify those numbers in this upcoming research as a precursor to kicking off that research work stream. We had a number of folks participate in the qualitative interview and the burden or the biggest pain points that they had mentioned at that time was really the time impact and the fact that it was inefficient in terms of the resources on their teams as well. That’s just some qualitative insights in terms of the time and inefficiency in the process. But we will quantify the impact of the burden through that market research.

You’ll see a polling question here, and this is less of a poll and more of a “if you have an interest to participate in that Diligent and Tufts research”, just click on the button and we will follow up with you and make sure you get that link in your hands.

Let’s talk about vendor qualification today with Diligent Pharma. We have solved for the inefficiency through our process innovation. A provider completes the RFI templates and audit process once. Diligent holds those qualification credentials in our centralized platform and we enable the release of that data to interested sponsors through our secure interface.

We call it a process innovation because it’s a different way of working compared to what the traditional way is for vendor qualification. “Innovation” as a general term is getting a lot of buzz around the industry, around every industry these days. Everybody is hyper focused in our industry around reducing trial start-up times, often connecting the need for innovation to accelerate time to market. Leaders that we’re talking to across the industry are suggesting they’re open to innovations that will lead to more efficient ways of working.

But the reality is that most of us are settling for the status quo because we’re in a slow to move industry. Change is hard. There’s fear of change that creates inertia, even with the simple process innovation that we’re affording the industry.

As a result, Diligent is working hard with both sponsors and providers to be that catalyst for change and adopting innovation and driving order and less chaos in the qualification process.

As I mentioned, we’ve created a process efficiency with centralized data in the Diligent Platform, Diligent Pharma is the neutral third party that sits between the sponsors and the providers in the process, to create that efficiency.

Our process innovation is very rigorous, follows global regulatory guidelines, is high quality and helps sponsors and providers remain highly compliant and manage risk as well.

We will have one of the leaders from our quality team talk about the rigor behind our process here shortly.

Our objective here, though, is to take those pain points that we talked about earlier and create benefits for both sponsors and providers. The key benefits of using our centralized platform for sponsors is higher compliance and better data quality, faster vendor onboarding, greater efficiency and cost avoidance, better risk-based decision making, shortening clinical trial start up times and enabling innovation with confidence.

We’re working with a range of sponsors across the industry. Here is a snapshot of the sponsors that are working very closely with Diligent today. We’ve been able to crack the code with big pharma down to the small emerging biotechs and everywhere in between.
One of our strongest partners on the sponsor side is Regeneron, and I’ve invited Nicos from Regeneron to share his experience with Diligent.

Nicos Zittis: Hi everybody. My name is Nicos Zittis. I’m the Senior Manager for Vendor Relationship Management at Regeneron and my responsibility is to qualify vendors for the Global Development Group. I’ve been at Regeneron for 2 and a half years and prior to that, I was with Merck for 15 and a half years, conducting the qualifications and leading the qualification team for fourteen of those years. I’ll talk to you about my experience in general, and what I’ve seen is then the qualifications and what we do currently at Regeneron with the Diligent.

As you probably know, those of you who are involved in vendor qualifications, there are several challenges that we deal with every time we try to conduct qualifications. Using the staff and the resources we have, we have to deal with multiple qualifications at the same time. All the time, those qualifications come with tight timelines

Most of the time, the requests say that the communication needs to be done as soon as possible. We conduct qualification using multiple questionnaires and those take time to prepare and review.
Our functional area subject matter experts are not dedicated specifically to vendor qualifications. They have their everyday responsibilities and on top of that we ask them to do vendor qualifications. On the vendor side, we have to deal with the availability of the vendor. It could be that they are involved in other audit qualifications. Depending on the time of the year, there may be vacation time, holidays and all that. Many vendors have resource constraints.

Some of the vendors we want to qualify and use are small and they don’t have many individuals on their staff. That causes the delays in responding and getting things done. Many times we also receive incomplete responses to the questionnaires we send and have to go back and forth and get clarifications. As a result, the follow up and everything else can cause significant delays in many cases.

The key benefits of using Diligent, as I see from my experience with using Diligent for our qualifications at Regeneron are: first of all, there are hundreds of completed RFIs in the Diligent database. So, when we do qualifications, I always look in the database and see if there are completed RFIs in there already. I would grab them and use them. I would say it cuts the time and effort that would be needed to get those questionnaires completed by the vendor down by 2-3 weeks from the qualification timeline.

Another service we use from the Diligent team is the RFI scoring. The Diligent team takes the completed RFI and they identify the weaknesses in the responses the vendor provided and Diligent then provide reports to us so that we can look at those reports and have our team conducting the qualification focus on those weaknesses and gaps.

Diligent also ensures that the questionnaires that we request are complete. They go back to the vendor and make sure that if there were any responses missing, or if something was not completed correctly, the vendor would correct that and they would deliver the complete questionnaire to us. In addition to how they do a quality review of the responses and we get a complete and quality RFI from the vendor.

In addition to that, we use the vendor audit reports that Diligent has in the database. Those are audits that they conducted for other sponsors. Up to this point, we haven’t asked Diligent to conduct an audit for us. We do that on our own, but we have used the reports to get information and enable our auditors and the qualification team in general to concentrate on those weaknesses that the audit report may show.

So everything works together: the completed RFIs, the follow up with the vendor on our behalf and not having to do that on our own and the audit report – everything in my view translates into time savings.

I don’t have to spend time following up with the vendor. I don’t have to worry about getting a complete response and review it entirely myself and making sure that nothing was missing.
All together, we see a benefit that we get from our partnership with Diligent, enabling us to conduct more efficient and time saving qualifications.

That’s all I had to say for the time being, I’ll be happy to answer any questions.

Chris Casazza: Nicos, thank you very much for that perspective and for Regeneron’s partnership with us today. We appreciate it. Now let’s jump over to the benefits for providers. We talked about some of the pain points that providers feel in the process. Our goal is to help them accelerate time the contract with sponsors, showcase their innovative services, reduce the qualification burden and drive internal efficiency and improve their risk awareness and become more or highly inspection ready.

Our community of providers is growing significantly. We’re at about 1200 providers and counting, and I’ve asked one of our providers to join us today from GenVault. I’d like Andrew to say hello and talk about the experience with Diligent today.

Andrew Lee: Thank you. It’s nice to meet everybody. My name is Andrew Lee, and I’m the Executive Director at GenVault. I came from the cancer/oncology and Precision Medicine space. I worked there until I moved on to run a GXP gene therapy manufacturing group for a period of time before moving on to GenVault where we run about 400 clinical trials at any given time and we have a multitude of different clients.

GenVault is a large buyer repository and 3rd party logistics companies. We take a lot of samples under a cold chain sort of scenario and then store them off site for a lot of our clients. What that means is that we have business, academia, research and development groups, preclinical and clinical.

We have folks in reproductive medicine, large and small pharma, a lot of therapeutic companies, even gene therapy and in general, just GXP manufacturing groups, it’s very common for us to work with them. GenVault itself is a very large buyer repository, one of the most accredited buyer repositories in the world. Because of that, we have several accreditation bodies that come in and will do regular audits with us and then we have a lot of clients that will come in and do audits with us. And so, we’re really based on the idea that we’re going to spend money on infrastructure at a much larger scale than you ever would for yourself. We’re going to have more backup redundancy generator power. We’re going to have a higher quality facility. We’re going to have a rapid response team that’s there and we’re going to have fleet services that can literally do white glove sample transfers for you.

We can store all of your data and we can have the incoming and outgoing samples logistically much faster than our competition can. Generally, we can pull a sample in about two hours and have it on the road to you, and in most cases, our our clients really need that because they store with us long term, but they also store with us on a very temporary basis depending on what clinical trial they’re running or what their research needs are. And so, we’re really the cold chain experts in this space and because of that and because we service so many industries we have to hold to these accreditations and there’s a lot of overlap even between clients that are national and international.

For example, CCTV footage has to get deleted for our international clients from some places and then here in the US we can keep it sort of as long as we need to for security reasons. Some of our government clientele and also the FDA themselves prefer that we hold on to that footage in some cases. And so because of that, there’s a lot of overlap for a lot of our compliance items and because we have so many industries that we service, it really means that we have to be held to a very high standard from a lot of different kinds of auditors in this space.

One of the reasons that we decided to work with Diligent is to try to get through this process in a very upfront and robust way. We want Diligent to come out and audit us as tough as they can be. We want to pass every single criteria they can put in front of us.

And we want to make sure that we’re upholding that standard to our clients because we get what I would call a full service audit. Our clients look at every service we provide, probably somewhere between 20 and 25 times a year. What that really means is that by the time they take all of our accreditations, that only allows me to onboard about 18 clients a year, which is not very many and it’s a lengthy process. You have to get a hold of the vendors and you have to have their audit team schedule and sometimes that’s a six month window.

You get an audit report and you have some finding you have to respond to and by the time you get through that process, the sales cycle itself is very large and it can mean that onboarding clients to the satisfaction of their teams can sort of miss the window where they really would like to use us. And because we offer a lot of services like disaster planning- for example, if a client needs to have samples off site and wants to store them with GenVault, usually there’s a very good reason for that and it’s required by their accreditation and there’s a very tight window with an inspection or an audit on the client’s end that they have to be upheld to. They have to be able to be confident that they can come to GenVault and say “the FDA is auditing me. I need the materials and I need you to give them to me now” and be confident that GenVault’s team not only can send the physical materials but also get them through their audits and help them meet their qualifications and not be a headache when it comes to the data or the limbs or the processes themselves.

And so working with Diligent really solves a lot of our problems. It allows us to onboard our clients. It allows us to take some of these contract delays that we see or that inconsistent auditors from different industries and wrap them up into one section that will allow us to do business more efficiently. And in general, as an executive administrator, I love the idea of being able to look at the revenue and not have these sort of speed bumps in the road. So from an efficiency standpoint, it really makes me happy.

This slide really just highlights some of the contract approach consistencies, some of our service offerings and then on the audit time reduction itself, which is probably the biggest component that we see and need the help with. But for us, if we can find a way to optimize contracts by working with Diligent, it will not only solve the major problem for us, but I think it’s going to mean more revenue, easier business and in general probably a lot of cost savings, not only for our team as a sponsor for all of these audits, but for the clients themselves, that constantly have to send out audit teams and plan visits and book flights and everything else that’s required to run a good audit.

Chris Casazza: Excellent. Thank you very much for your perspective, Andrew, and we look forward to unlocking the opportunity with GenVault. It’s an exciting time.
Jay, I’m going to hand it over to you to talk about the rigor behind our qualification process.

Jay Turpen: Thanks, Chris. My name is Jay Turpen and I’m a Senior Advisor for Diligent. I’ve been working with Diligent since 2020. Before that, I was a a Senior Consultant with the Avoca Group, managing Quality Improvement Projects and before that, I spent 29 years at Lilly in various leadership positions, retiring at the end of 2017. It is my pleasure today to talk to you a little bit about our qualification process.

First, maybe just a little history lesson of where we came from. Our roots are in the Avoca Quality Consortium, which was is a collective consortium of pharmaceutical, biotech and provider companies. I think the latest number I heard, there’s more than 200 companies that are in the AQC (the Avoca Quality Consortium).

It was founded in 2012, and they began working together on quality improvement initiatives that would benefit the industry in a pre-competitive mode and during that time one of the first work products that came out was a set of qualification standards for providers. That really is the foundation that we build our qualification process on, the qualification standards that have been generated through the Avoca Quality Consortium.

In 2017, Diligent was formed. We grew out of the Avoca Quality Consortium. There was a pilot that was run to test the hypothesis of how this would work, how we would create a platform of data services to manage the qualification process. The pilot was successful in 2018, there were a large number of RFI’s exchanged and it included multiple sponsors and many service providers that participated in it. Based on the success of that pilot, Diligent as a company was formed and we eventually were spun out of the Avoca Quality Consortium as an independent group. As I mentioned, I started in 2020, had been with Avoca, and moved over into the Diligent side of the business, and since that time, we’ve grown significantly.

Our platform has grown, its capabilities have grown. In 2022, we really started offering RFI scoring, which I think you heard Nicos talk briefly about, and I’ll speak to that in just a moment – and also, our VQA library was launched on the platform. Today, as Chris mentioned in the beginning, we have over 1200 providers on our platform and a large and growing number of sponsors that subscribe to our platform. And we’re bringing new efficiencies to the industry.
For anyone in the GCP/GCLP space, I think we all have experienced a large number of requirements that we need to meet to conduct our clinical trials.

The purpose of our vendor qualification efforts are to ensure that all providers are in compliance with meeting the expectations of these various regulations that apply to their business, and so we, in our qualification process, test and evaluate the compliance posture of each of these providers against the expected standards.

There are three in particular that really form the requirements for doing a vendor qualification. We’re going to talk a little bit about ICH Q9 Risk Management, ICH Q10 the Pharma Quality System and and the foundational ICH E6 R2, which really lays out the requirements for clinical trials. When you take a look at Q10, it clearly says that companies that are managing clinical work and any kind of pharmaceutical development have to have a quality system and they have to ensure that they do have control and review of any outsourced activities.

At the end of the day, the pharmaceutical company is accountable for the processes that are being done by their providers and the Q10 actually says it’s important to assess those providers before you outsource the work to make sure that 1). they’re qualified and understand their obligations, and 2). that in fact you want to take on the associated risks of those providers before you move forward and then ultimately provide oversight of those vendors.
Q9 came out and really focused on how you do a risk based approach to all of this. In that process there’s risk assessment and risk control that’s clearly an expectation and we believe our qualification steps are actually the beginning of doing a risk assessment and establishing risk control for outsourced work that goes to a provider. And then very specifically in E6 R2, it says that a sponsor can transfer duties to a CRO.

In my experience, I’ve seen clinical trials that had operated with as few as 4 outside providers. And I’ve seen it as large as 20 providers that are all working together on a single clinical trial. So for sponsors in this day and age to deliver clinical trials, there’s a large group of providers that are working together and those sponsors need to have oversight. They need to ensure that oversight is taking place because at the end of the day, they’re accountable for the work product and ultimately we believe that it points to the need for vendor qualification as that initial establishing of their competency and capabilities to be doing that work and to be compliant with all applicable regulation.

We see ourselves as a partner to both providers and sponsors. As we’ve heard today, there are benefits to both sponsors and providers in using our services to streamline this whole process.
So how do we do that? Well, first of all, every provider that we evaluate gets evaluated against a core set of standards. These standards cover things like the organizational structure. Do you have an independent quality assurance group? Are you financially stable? Do you have adequate insurance for the work you’re being contracted to do? Do you have policies that address global expectations around ethics, anti-corruption, anti-bribery and and take a look at the organization as a whole. We also look at every provider’s quality management system. We review all of their SOPs and requirements to meet obligations. We make sure that if any part of the work is being outsourced to another third party, there’s a third party quality management process and that you have document control processes and take a risk based approach. We also look at data privacy and data protections. We need to make sure computer systems are validated and meet all of the the regulations around that and that they’re also compliant with GDPR from Europe and other locations that have that as well as HIPAA.

We need to make sure that all data is handled in an appropriate way and then lastly, we cover things like how data is handled and transferred internally and to the sponsor, how staffing is managed, to what degree is staffing done internally versus subcontracted.
Is training adequate and up to date? And are the facilities fit for purpose for the services that are provided, particularly if there’s sample handling, are those sample handling facilities adequate for the types of samples to be processed in their control?
Once we’ve looked at those core standards, then depending on the sets of services that are being provided by that provider, we will then add to the core standard these specific functional standards that apply. We start with core [standards] and then we add to them the specific standards. I won’t read all of these but over in the upper left hand corner we have the CRO traditional services and the list keeps growing. But if we’re talking to a full service CRO, we’re looking in the upper left quadrant for those services.

If it’s a lab or an imaging company, we have standards that address different kinds of laboratories or images, including things like BMI, MRIs, EKGs, X-rays, etcetera. And we also cover all kinds of laboratories, including biomarker and bioanalytical labs.
And then lastly on the right hand side, we cover all kinds of e-technology services, SAAS services that support clinical trials. The right-hand side has grown tremendously over the last five years and particularly accelerated during the pandemic as more and more services were handled through platform services rather than the traditional approach.

Based on these requirements, we pulled together our qualification approach that meets the needs of our individual sponsors.
How that looks and this is just kind of lifting the lid a little bit on how this happens: we have qualification standards which are in this upper left hand corner for every type of service in that qualification standard, there’s a set of expectations. We refer to the predicate rules of what regulation requires that and then from each of these qualification standards there’s a set of questions that are in our RFI.

In those RFIs there could be one or two or three questions related to each qualification standard statement.

These RFIss are filled out by providers and those come back to Diligent and sit on our platform. We have a service of scoring these platforms for our sponsors and we will read these with our subject matter experts and then highlight for the sponsors, any questions that require additional review on their part that isn’t clearly compliant with the expectation so that they can determine their tolerance for that risk and whether they want to go further with follow up or accept the risks as part of their risk oversight.
And then lastly, we have auditor-led qualification audits that we perform. Once we perform one of these audits, we write our report and that report ultimately goes on our platform and is available for request for future providers. So that’s a quick overview of our Diligent process.

And I’ll turn it back to you Chris, for further comments.

Chris Casazza: Thank you, Jay. Appreciate that grounding for everybody’s benefit and the depth and rigor behind the Diligent process. I’d like to transition over to one of my commercial partners, Peter Haessig, to talk about our provider engagement model.

Peter Haessig: Excellent. Thanks, Chris and appreciate that overview, Jay.

My name is Peter Haessig. I lead the Client Partnerships team here at Diligent Pharma. My team manages our provider partnership offering. We work closely with our service providers to help maximize the ROI they get from being on the Platform which is primarily the reduced qualification burden you’ve heard about today and accelerated sales cycles.

I’m first going to take us through a brief video demonstration that describes our qualification process at a high level, but also gives you a look at the technology behind it and really the delivery mechanism for how providers can release their data to sponsors on the platform.
We qualify GCP and GCLP providers vendors through highly rigorous process adhering to global regulatory standards. As Jay just described, any regulation that will apply to a provider if it’s relevant to your business, we will check it.

These are then in the form of the RFI/qualification questionnaires or the auditor-led Qualification Assessment Audit reports.
Pharma and biotech companies can quickly discover providers through our interface and then request and download these qualification credentials through the secure interface. This is done only through the express approval of the Provider. The data is not public to be shared, it’s very secure.

From a sponsor perspective, procurement teams get excited about the ability to access instant RFI data across these 31 service categories. The quality teams get excited about the access to the rigorous audit reports, eliminating the need to wait months to conduct that new assessments, relieving some of the burning we heard about earlier.

Key for the sponsors is that with all these hundreds of providers pre-qualified and at their fingertips they’re able to drive higher quality compliance and cost savings at the end of the day expediting the process of getting critical medicines to patients. Which is really what we’re all here for!

To summarize, our Diligent process, the output from that qualification is a highly rigorous qualification package. The audit report and the RFIs for providers to manage on the platform. As you heard from Jay, we’re not talking about checklists that simply describe your services. These are highly targeted RFIs and reports from independent auditor-led assessments that can represent your capabilities and compliance posture with objective authority.

The data is secure and in your control. I really want to highlight that no one can simply access your RFI’s or your audit reports without your express permission.

Sponsors and clients make requests for the data. The providers users must approve or deny those requests, and it’s an enhanced security control that we built in to the technology process.

Lastly, this data can and should be a current reflection of your capabilities. The RFIs are for you to maintain in the system and can be updated before each release to the sponsor. While the audit reports themselves do represent a snapshot of your business at any given time, our process allows providers to get real-time updates. Things like the current status of CAPA implementation and material business changes when releasing these reports to sponsors.

We want to enable providers, give them the agency to manage the qualification process on their terms. Your data is complete, it’s secure, it’s in your hands to represent your capabilities as they evolve and Diligent is simply the independent body through which sponsors can qualify you very rigorously and very quickly.

I’m now going to talk about our provider partnerships. Providers can simply manage their RFI data on the platform for sponsors to request. We can also work more closely with the provider to really maximize that ROI that I was talking about in the beginning here. Through our partnerships, we help providers take a proactive compliance approach that yields greater adoption from sponsors, puts them in a better position to win new business, host fewer qualifications and accelerate that sales cycle.

Essentially, through our engagement model, we can manage every single qualification request a provider receives from the sponsor, regardless if they are already familiar with our platform or service, are a current client or yet to be a current client.

And as you see here on the screen there are three main components: 1) an annual qualification assessment which our team will conduct; 2). client support and solutions and 3). commercial alignment.
In a provider partnership, we will conduct the annual qualification assessment of your services that Jay outlined earlier in order to keep that data fresh.

We can then engage with every sponsor that needs to qualify you, offering our SMEs as resources who can then help educate them on the credibility of the Diligent qualification, describing our expertise and our rigor, and in particular, the regulatory agencies’ acceptance of this qualification model. We understand it’s new and we need to educate people that the authorities have given this the green light.

The third pillar is important as well. It’s commercial alignment, so we want to provide your sales and marketing teams with the support they need to leverage the partnership successfully as a true value add in that sales process. Andrew was talking about that in particular. We’ll provide things like sales training, develop collateral that can help educate your sponsor clients that using Diligent qualification data is high quality and compliant.

We create marketing campaigns to target key prospects of yours that might be out there in the market. Combining these elements can greatly increase the success and ROI from being qualified by our team.

Here is an example of that sample business development collateral we can provide in a partnership to your teams describing our process, our rigor, the scope of the assessment, answers to some commonly asked questions specifically about our credibility among regulatory bodies.

So if we have time for a quick poll, I’ll leave this up on the screen for a little bit. I’m curious what the audience thinks. Based on our experience to date working with sponsors and providers, how many days on average do you think our process has saved sponsors and providers in that single assessment? Please respond and then I can share some of our real data.
• 50 to 75 days looks like it’s the winter here.

We’ve actually been able to shed on average 100 days from the qualification process. It’s been quite impactful, right? Through polling our clients and providers, aggregating qualification data for secure reuse, we found our model enables strong compression of the qualification timeline. Over 100 days is huge, right? That’s from initial sponsor to provider contact interaction to RFI request to even through that assessment audit process. Taking 100 days off the process saves everyone a lot of time and money.

Drilling down in a more granular space, providers that are in partnerships with us right now, spend an average of two hours of effort on each qualification.

I know that sounds crazy, but if you think about only having to approve releasing that data through the platform to a sponsor… Yes, you have to review the initial request, see if any updates might be needed.

If you think about the typical process of prep, hosting that two day audit, responding to CAPA, going forward time and time again shrinking that to an average of two hours of effort is quite impactful.

And providers tell us they’re able to be qualified in the eyes of their sponsors within an average of five days, which again is huge.
I’ll end with this, to bring it to more of a macro level on our platform, we’ve to date been able to process over 800 qualification exchanges through the platform. Connecting sponsors and providers in that way has resulted in a 60% reduction in the cost for qualification that both sides enjoy. As previously mentioned, we’re able to shave 100 days off the qualification process simply by connecting sponsors and providers through this information sharing. We’re saving both sides time and resources and having a meaningful impact on reducing trial start-up time, which is something we’re proud about.

Chris, I’ll flip it back over to you. I think you might have some time for Q&A.

Chris Casazza: Absolutely. We have about 7 minutes left and you can feel free to type your questions into the questions widget. I’m seeing a handful of them pop up already.

One out of the gate and thank you, Peter, for sharing the provider partnership perspective, but also the value that it provides both providers and sponsors. And one question related to that is “Do sponsors need to subscribe to Diligent to get a providers report?” I will take that.

The greatest value in terms of ROI that a sponsor is going to get with us is being in a subscription model with Diligent. That said, our goal is not to create any friction in the process of getting sponsors and providers into a relationship quickly. We do offer that flexibility to get a provider report to a sponsor without forcing the sponsor to be in a subscription model. There’s tons of other benefits of being in a subscription, so I don’t want to diminish that, but in terms of the one off transactions, we enable that through the Diligent Platform.

Chris Casazza: Another question here: “Have regulatory bodies inspected Diligent sponsor clients and their use of the Diligent model to qualify providers? If so, has your model passed this scrutiny?” Jay, can you answer that from a quality perspective please?

Jay Turpen: Sure, Chris. Thanks. Yes, we have gotten feedback from our clients that they have been inspected and have successfully satisfied regulatory questions around qualifications that we’ve done, so that’s good news. Even as we started this model back in 2017, there were preliminary discussions with FDA about whether this concept was going to work. And although they will never endorse an individual company, they had no objections to what we were proposing. If you think about it, there are lots of contract people out there that are doing audits on behalf of sponsors.

We’re a subcontractor, if you will, to sponsors and serve as an independent QA organization for them. We’ve heard nothing but positive feedback on this front.

Chris Casazza: Thank you, Jay.
Next one looks like it’s from a provider. “I know my clients and they will want to do their qualifications their own way and directly with us. If my company wants to partner with Diligent, how can you convince my sponsor clients that using reports and RFI’s from Diligent is a compliant way to qualify us?”
Peter, do you want to pick that one?

Peter Haessig: Yeah, sure, Chris, thanks. The key thing here, I think it’s all about what we offer up in our SME support in educating the sponsors that you have in question.

When we’ve been able to get on the phone with the sponsor and describe our credibility, our rigor, our process, what the qualification encompassed, we’ve been able to satisfy them that we’ve done a extremely rigorous qualification that’s maybe even more rigorous than what they were planning to do. We’ve seen a lot of success – it’s about teaming up with your teams, you giving us the agency to interact with your sponsor clients, representing you as the independent third party that has done this rigorous effort goes a long way and makes it successful.

Chris Casazza: Peter, thanks for that. It looks like this one is an off-shoot to that topic. “What if sponsors still insist on conducting their own audits of us? How can Diligent help?”

Peter Haessig: I’d say two things here. What we often do is we’re still able to provide our qualification to that sponsor. And what we’ve seen often is that they look at the rigor of what we’ve done and even if they still insist on doing their own assessment (maybe it’s for their SOPs), maybe it takes that assessment down from the three days to one day, from 2 days to half a day because we’ve already done a lot of the work they were going to do anyways.

There’s also another avenue we do here. We can still manage that qualification on behalf of that sponsor as any other third party would. And we’ve also had success in what we do, we’re calling it Crowdsource audits. We can even then look at the next 4 sponsors on your audit list, for example, combine them into a single Diligent audit. Everyone remains confidential in the process, but we’re still able to alleviate the audit burden from the provider in that sense. And get everyone the data they’re looking for.

Chris Casazza: Peter, while I’ve got your attention on the provider impact as well. So “From your experience to sponsors typically need more information from a provider after receiving the RFIs and the audit report?”

Peter Haessig: That’s a great question. We did a poll of our sponsor base. They said after getting the audit report and RFIs, in 90% of the time, the data completely satisfied what they were looking for in terms of qualifying that provider. Sometimes follow up is needed. There might be bespoke questions that they want to add to the existing RFI or other questions they want to ask in the form of half day audit.

But typically, our experience to date is that it can really satisfy the full audit or shorten it significantly, to make you know the time savings.

Chris Casazza: Thank you. I’ll just take one more question here. “What segments of sponsors are getting the most value from the Diligent model for qualification?” I’ll take that one. I shared a slide earlier that had a snapshot of some of our subscribing sponsors and it’s a range of sponsors.

From the large pharma organizations, to the mid-size market, to the emerging biotechs. The emerging biotechs are trying to do things very quickly and efficiently without the embedded teams in place. So leveraging our model for that helps them be extremely efficient in the process. I would say that our sweet spot is really the mid-sized market. They’ve got teams and processes and structures in place that are growing and they need to add headcount. Plugging in a process innovation like Diligent into that process can help with some of the cost avoidance and further add efficiencies to the organization.

We are exactly at time right now. I want to thank everybody for your patience with us with a couple of the technical challenges we had to get started. Thank you everybody for your attention, for the questions you’ve asked. You’ll be able to access this link, we’ll get it out as a follow up and you can still ask questions in the in the days to come as well. We look forward to your feedback and thank you again. Have a great day.