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Enhancing Vendor Oversight and Communication Strategies in Clinical Trials with Jessica Cordes · Lab to Lives

• 0:21
  Speaker 1: Welcome to Transformation in Trials.
• 0:23
  Speaker 1: This is a podcast exploring all things transformational in clinical trials.
• 0:27
  Speaker 1: Nothing is off limits on the show and we will have guests from the whole spectrum of the clinical trials community.
• 0:33
  Speaker 1: And we're your hosts, ivana and Sam.
• 0:38
  Speaker 2: Hello everybody and welcome to another episode of the Transformation in Trials podcast.
• 0:43
  Speaker 2: Episode of the Transformation in Trials podcast and today I'm delighted to be joined by Jessica Cordes, who is a senior consultant and trainer at the Clinical Excellence Consultancy.
• 0:52
  Speaker 2: Welcome to the show, jessica.
• 0:55
  Speaker 3: Thank you for having me Nice to be here.
• 0:58
  Speaker 2: Yeah, we're really excited to have you on the show today.
• 1:00
  Speaker 2: You've got a great reputation in the industry and put out some pretty prolific content on LinkedIn as well, and we're going to get to learn all about your background in this space as we get into the podcast episode.
• 1:13
  Speaker 2: But, like with all of the other episodes of the Transformation in Trials podcast, we do try to theme every episode around a certain topic and, just given your background and experience, today's topic is going to be vendor oversight and getting ready for the latest GCP guidance Sound good, that sounds amazing.
• 1:36
  Speaker 2: Awesome.
• 1:37
  Speaker 2: All right, let's get into it.
• 1:38
  Speaker 2: So first topic we wanted to touch upon is quite broad what is vendor oversight in clinical trials and really, why is it important?
• 1:51
  Speaker 3: Yeah, so actually it is a broad spectrum.
• 1:53
  Speaker 3: Sponsors need to think about so.
• 1:58
  Speaker 3: In first instance, vendor oversight is a process to oversee the service providers you are assigning tasks to as a sponsor and you have a contractual agreement with those service providers.
• 2:15
  Speaker 3: So it's all about complying to the regulatory requirements.
• 2:22
  Speaker 3: You have to ensure that you have suitable vendors in place.
• 2:25
  Speaker 3: You need to comply with good clinical practice we all know.
• 2:31
  Speaker 3: So this is all about vendor oversight.
• 2:33
  Speaker 3: Another aspect is you want to mitigate risks and you want to protect you as a sponsor from being non-compliant.
• 2:46
  Speaker 3: That's why you need to have a certain level of control oversight over the vendors you are involving.
• 2:55
  Speaker 3: So very broad.
• 2:58
  Speaker 2: Very broad, because I would imagine there's some opinions in the industry whereby, look, I'm paying vendors to do a job here, I just want them to get on with it Like, what's my responsibility here?
• 3:12
  Speaker 2: I agree, yeah.
• 3:15
  Speaker 2: What would you say to that?
• 3:19
  Speaker 3: Oh, I often heard and I can even add a side note here I don't need own team members because I'm outsourcing all responsibilities to a service provider.
• 3:31
  Speaker 3: In old days probably this was an adequate approach, especially with a revision three of good clinical practice practice.
• 3:48
  Speaker 3: We now see that it's the ultimate responsibility of a sponsor to oversee the quality, the data reliability and the patient safety of the clinical trial, meaning the sponsor is obliged to oversee the service providers being involved.
• 4:01
  Speaker 3: So nowadays we need to admit there is no chance.
• 4:06
  Speaker 3: If you outsource your responsibilities, you are still in the same boat and you need to oversee those activities and how.
• 4:16
  Speaker 3: You need a team to oversee the CRO, so probably you have less people in your, so probably you have less people in your sponsor clinical trial team than a CRO, for example, especially for global or big clinical trials, late phase clinical trials.
• 4:43
  Speaker 2: But even with one FTE only, I would doubt that you can fulfill your sponsor responsibilities, totally understood.
• 4:49
  Speaker 2: I'm wondering if some people in the future might think that, dare I say it, ai, ml and bots may be able to take on some of this oversight burden perhaps, but I'm sure we'll get on to technology's role in all of this as we get into the discussion.
• 5:04
  Speaker 2: So, yeah, yeah, great introduction.
• 5:07
  Speaker 2: What are some of the challenges that are impacted by poor vendor oversight?
• 5:13
  Speaker 2: We have to do it.
• 5:14
  Speaker 2: Obviously.
• 5:15
  Speaker 2: You told us that it's the regulator that says we have to do it, but if we don't do it, or don't do it well, what can happen?
• 5:23
  Speaker 3: Yeah, do it well.
• 5:29
  Speaker 3: What can happen?
• 5:29
  Speaker 3: Yeah, unfortunately, there are various impacts you can see by poor venereal performance and I've been through some of them already personally, so it's learning by pain.
• 5:35
  Speaker 3: First of all and most importantly, you risk the safety of your patients, of your participants, of your clinical trial, and this is where we are all talking about patient centricity and the sponsors should focus on right.
• 5:54
  Speaker 3: We are here to develop drugs for patients.
• 5:58
  Speaker 3: Because of the patient's sake.
• 6:00
  Speaker 3: This should always be our prior one, and you run risks in not identifying issues for the patient's safety.
• 6:09
  Speaker 3: So that's a very, very massive, important aspect.
• 6:16
  Speaker 3: But at the same time, you can face some quality problems in collecting data, in communications, in preparing documents, maintaining your trimaster file.
• 6:29
  Speaker 3: There are so many aspects related to quality you can face with poor vendor performance that you should better oversee the performance.
• 6:41
  Speaker 3: At the same time, you can get compliance issues and we all keep inspection readiness in mind and when it comes to quality and compliance or, in this case, non-compliance then obviously you collect all the data and you want to submit for market approval at some point and you have the risk that your data are not getting accepted.
• 7:05
  Speaker 3: So it's better and wiser to oversee your service provider performance from the beginning to ensure that you have adequate data in the end you can use to submit for market approval.
• 7:20
  Speaker 3: And, as mentioned before, you can face some communication breakdowns if the vendor and, let's be fair, full-service CROs are high-risk vendors for clinical trials.
• 7:35
  Speaker 3: If there is a communication breakdown, your clinical trial can crush and you can have massive impacts here as well, right, crush and you can have massive impacts here as well, right, and the business models are varying from from the business models we see at the sponsor side, leading to the fact, unfortunately, that most of the time you as a sponsor, you are getting informed of a of an internal issue right before it's too late.
• 8:05
  Speaker 3: So better start your vendor oversight very early to keep track on things going.
• 8:12
  Speaker 3: And latest point from my end would be you run the risk to have increased costs and delays for your clinical trial because the vendors probably have mentioned they have conducted an activity and they are done, and then you realize, oh gosh, the data are still missing, right?
• 8:35
  Speaker 3: So consider a phase one clinical trial where the dose escalation, where you need to clean the data and get them prepared for data monitoring committee on time, the CRO is indicating clinical monitoring activities, data management activities completed, we can prepare the data set for the DMC.
• 8:58
  Speaker 3: And then you get the data extract and you realize I don't know, know, 50 of the data are missing.
• 9:05
  Speaker 3: You know, but it's late if you realize that during the prep for the dmc.
• 9:11
  Speaker 3: So you need to postpone the dmc and this will have an impact on your overall clinical trial timelines, and this is something, as a sponsor, you don't want that yeah, I think you unpack that really nicely.
• 9:25
  Speaker 2: There's so many dependencies, it sounds, between what happens during the conduct of a trial and beyond, and oversight seems to play a big part in mitigating against some challenges which may cause some of these dependencies to then fall out of sync, it sounds, cause some of these dependencies to then fall out of sync, it sounds.
• 9:44
  Speaker 2: I'm also glad you said about safety as well, because that has to be the number one priority here.
• 9:50
  Speaker 2: Patient safety, patient centricity often gets lost in the discussion, and you touched upon a number of other key areas too, because I think sometimes when people talk about vendor oversight, it gets grouped as potentially a tick box type exercise, something you have to do because the regulator says so.
• 10:09
  Speaker 2: But the points you just raised, it sounds like there's a lot more to it than that.
• 10:13
  Speaker 2: I mean you touched upon some of these already, but are there any?
• 10:17
  Speaker 2: Everybody talks about metrics.
• 10:19
  Speaker 2: In our current climate, everything needs to be measured somehow.
• 10:25
  Speaker 2: If it's not measured, it's not managed, as they say.
• 10:27
  Speaker 2: What kind of metrics are impacted by a lack of effective or robust oversight?
• 10:36
  Speaker 3: Yeah, that's a simple question and we can talk for days or weeks to go through all metrics components, so let's keep it high level.
• 10:48
  Speaker 2: Give us your perspective on the importance of metrics as well.
• 10:50
  Speaker 2: I'm curious to hear that too.
• 10:52
  Speaker 3: Yeah, so I recommend to think about the risks you have identified, and we have listed the risks already right.
• 11:00
  Speaker 3: So, starting with patient safety, this is a high risk if you lack sponsor oversight for your vendors.
• 11:08
  Speaker 3: So think about which key performance indicator, key risk indicator, you can implement for the topic or for the functional area of patient safety.
• 11:19
  Speaker 3: So it's something around adverse event reportings, number of SAEs or identified delayed SAE reportings, or you import data as a mitigation.
• 11:35
  Speaker 3: Then we are more with percentage of errors while importing data.
• 11:41
  Speaker 3: So these kind of metrics you can implement for patient safety.
• 11:47
  Speaker 3: Considering the compliance topic, so you can go with, for example, a number of non-compliances per site, per patient, per visit, per time period, per, whatever right.
• 12:03
  Speaker 3: So it's really flexible.
• 12:05
  Speaker 3: None of the guidelines is giving you such detail that you are pressed into a specific approach, but you need to come up with smart key quality indicators here as well.
• 12:20
  Speaker 3: So you can go with number of protocol deviations or data discrepancies.
• 12:27
  Speaker 3: If you go with quality, if you go with compliance, then probably maybe seriousness or audit findings or self inspection findings could be something.
• 12:43
  Speaker 3: And you also want to consider timelines like cycle times.
• 12:53
  Speaker 3: So in general, you can go with number of months delay in your total clinical trial timelines, but you can also look at cycle times like number of months between finalized protocol and approval received, or site selected or approval received until site initiated, those kind of things like typical key performance indicators.
• 13:23
  Speaker 3: And you also might want to address the cost topic where you can have percentage of budget used or percentage of budget discrepancy.
• 13:38
  Speaker 3: Those kind of things can go into your metrics.
• 13:42
  Speaker 3: So a whole bunch of topics and as a sponsor you should decide in which level or in which granularity you want to run those metrics.
• 13:56
  Speaker 2: Sure, there's no kind of out-of-the-box toolkit of metrics.
• 14:01
  Speaker 2: No, unfortunately no toolkit of metrics.
• 14:03
  Speaker 2: No, it's which which is unfortunately no.
• 14:05
  Speaker 2: But I guess, like they should, to a degree, be flexed to the individual situation, unless you can standardize these things across different sponsors and therapeutic areas.
• 14:17
  Speaker 2: Maybe, yeah, um, and I think that that kind of leads to the next point around approaches to developing and executing a robust vendor oversight framework.
• 14:30
  Speaker 2: Because, as you started to unpack this topic, if I were a sponsor, particularly a small sponsor, and had limited resources or knowledge on this, I'd be thinking to myself where do I start?
• 14:43
  Speaker 2: And, yeah, how do I get my arms around this and both plan and execute it?
• 14:49
  Speaker 3: so curious if you could help our audience at least have some of the high points and things that they should be considering here yeah, in best case, you do have a standard operating procedure already in place giving you the process, steps and the key considerations you need to comply with.
• 15:10
  Speaker 3: So, overall, you need to define your roles and responsibilities clearly, both from you as a sponsor but also as a vendor, to ensure that every party feels accountable as a vendor, to ensure that every party feels accountable and that's only possible if you know what you are assigned to do.
• 15:34
  Speaker 3: Right, you should think about the SOP framework and how you bring vendor oversight into your SOPs as a sponsor.
• 15:41
  Speaker 3: There are still CROs out there being a little bit surprised when sponsors say oh, I want to have that checked, I want to review this, I want to approve that.
• 15:54
  Speaker 3: That's part of sponsor oversight and vendor oversight is part of sponsor oversight, right?
• 16:01
  Speaker 3: So, in best case, harmonize your approach throughout your clinical trials and it's really starting from the planning phase.
• 16:12
  Speaker 3: And that means, when it comes to vendor oversight, the vendor selection process is already part of the vendor oversight and for me, the very, very first step is really about roles, responsibilities and your specification.
• 16:30
  Speaker 3: So I call it vendor profile.
• 16:34
  Speaker 3: Which kind of vendor are you looking for?
• 16:38
  Speaker 3: Please sit down and clarify on your end.
• 16:42
  Speaker 3: I often hear from sponsors.
• 16:45
  Speaker 3: Oh, for purpose I don't give too much detail because I want to see how the CRO is providing the cost quote.
• 16:53
  Speaker 3: It's a fair point to receive feedback from the CRO to see how experienced they are, but probably you have apples and pears in the end and you can't compare the cost quotes because of different assumptions, can't compare the cost quotes because of different assumptions.
• 17:12
  Speaker 3: So my recommendation is sit with your own team to come up with your roles, responsibilities and assumptions for your clinical trial and have that as a starting point for your vendor selection.
• 17:25
  Speaker 3: Then the risk management is a hot topic Also, vendor oversight should have a risk-based approach.
• 17:37
  Speaker 3: So, considering the vendor selection, you can have a risk management around the vendor you are selecting about financial risks, maybe resources, maybe competencies, expertise risks but also corruptions might be a topic Don't forget that right Anti-bribery acts.
• 18:03
  Speaker 3: But at the same time your vendor oversight should also be risk-based.
• 18:07
  Speaker 3: So here, once you have selected your vendor, you need to think about have you worked with this vendor before?
• 18:16
  Speaker 3: How is your experience?
• 18:18
  Speaker 3: Is it a long-term relationship with good performance?
• 18:22
  Speaker 3: Then probably you have the performance risks downgraded and not upgraded.
• 18:28
  Speaker 3: Otherwise I would recommend to look for another partner.
• 18:34
  Speaker 3: And then it's also dependent on the type of responsibilities you are giving to the vendor.
• 18:39
  Speaker 3: If you have a routine lab work, for example, outsourced to a lab vendor, then you might be able to downgrade the risk compared to a very specific genetic analysis which is exclusively set up and validated for your individual clinical trial Then maybe even it's an inclusion criteria.
• 19:06
  Speaker 3: Then you need to upgrade that risk right.
• 19:09
  Speaker 3: So it's really dependent on different things.
• 19:12
  Speaker 3: Then you need to ensure that you have a regular communication with your vendor, and here I'm thinking about scheduled meetings, but also status reports and the issue escalation process, and it's comparable to your private life.
• 19:31
  Speaker 3: Whenever you are happy with each other, you should better get prepared for the not so happy times, right.
• 19:39
  Speaker 3: So I would always recommend, once you are setting up your clinical trial, write an oversight plan how to communicate, but also add another layer of your vendor oversight I used to call it vendor governance which is not only on the trial level, but looking per vendor with a middle management on key performance indicators, more strategic overall awarded clinical trials per vendor, and if you're a bigger company, you can even add a steering committee.
• 20:21
  Speaker 3: Less frequent meetings, even more strategic thinking about business relationships, portfolio topics so you can even add more layers than just the one on the clinical trial management, another topic, so it's a broad topic.
• 20:42
  Speaker 3: Sorry, um, I still have a few points in mind.
• 20:45
  Speaker 3: I'll keep you going another topic is you need to ensure that you have the training oversight as well.
• 20:52
  Speaker 3: So that means if you're using the cro sops as a sponsor, you need to oversee what's included in the sop.
• 21:05
  Speaker 3: So better review and approve those sops in the beginning, but throughout the clinical trial you need to get communicated about any SOP changes, and the other way around as well.
• 21:19
  Speaker 3: If you want to push the CRO for your own sponsor SOPs to be used for your clinical trial, then obviously as a sponsor you must ensure that the cro team is trained appropriately for your sop.
• 21:37
  Speaker 3: So we touched performance metrics, key performance indicators.
• 21:41
  Speaker 3: So there is a lot of monitoring.
• 21:45
  Speaker 3: Beside the usual clinical monitoring.
• 21:48
  Speaker 3: It's more meant like tracking of of activities happening and issues happening, risks identified for your clinical trial, and this is leading to your audit plan.
• 22:02
  Speaker 3: So this is also part of vendor oversight, to ensure that the vendor is being qualified initially but audited from time to time, dependent on the risk score of the vendor throughout your clinical trial.
• 22:19
  Speaker 3: So hopefully we touched all the topics of vendor oversight only on a high level.
• 22:26
  Speaker 3: But at least it should guide the topics you need to think about yeah, that was great, jessica.
• 22:34
  Speaker 2: There's a lot there.
• 22:35
  Speaker 2: I'm sure we could do like a micro episode on each one of those topics that you outlined, and probably more, no doubt, um, it does sound, does sound like there's a lot there, a lot that people have to consider.
• 22:49
  Speaker 2: Are there, like, technology solutions in place that help people get to grips with this?
• 22:55
  Speaker 2: Obviously, there's process involved that you talked about here too, but, just like with everything, does tech have a part to play here?
• 23:03
  Speaker 2: If so, could you talk to us a little bit about that?
• 23:05
  Speaker 2: I'm coming from the biased tech angle here, so I always throw in another technology related question.
• 23:20
  Speaker 3: No worries at all.
• 23:20
  Speaker 3: Yes, for sure, there are already some vendors providing you technology to set up a robust risk assessment for your clinic as well.
• 23:23
  Speaker 3: There are vendors providing technical solutions for the vendor selection process, but also when it comes to centralized monitoring, tracking of your matrices, even communication ways, pushing notifications, visualization of your metrics, issue escalations.
• 23:47
  Speaker 3: All these kind of activities can be supported by technology.
• 23:52
  Speaker 3: Yes, and there are various vendors out there.
• 23:56
  Speaker 2: Understood.
• 23:57
  Speaker 2: What about on the people side of things then?
• 24:01
  Speaker 2: Whose responsibility?
• 24:04
  Speaker 2: Is it sponsor side for vendor oversight, or is it everybody's responsibility?
• 24:09
  Speaker 2: Does it sit within one function, for example?
• 24:14
  Speaker 3: well, I give you the the legal response.
• 24:17
  Speaker 3: It depends by lawyers, right?
• 24:22
  Speaker 3: Um, it depends on the company structure you have in place.
• 24:26
  Speaker 3: Um, all right, so it can be um.
• 24:31
  Speaker 3: Decentralized, meaning a vendor contracted by clinical operations is overseen by event.
• 24:41
  Speaker 3: Clinical operations functions typically the clinical project manager um, if you think about a drug safety vendor, um then obviously this vendor would be overseen by the drug safety manager.
• 24:57
  Speaker 2: Right Understood.
• 24:58
  Speaker 3: This is the decentralized approach, but there are also centralized approaches with more or less the midsize to big pharma probably, where you have already clinical outsourcing managers who are overseeing the vendor performance in general but being supported by the functional area experts like the clinical project manager and the drug safety manager.
• 25:24
  Speaker 3: But they are providing input to the status quo and the requirements and the clinical outsourcing manager is somebody who's in direct contact, is the primary contact for the CROs and is driving the oversight activities.
• 25:43
  Speaker 2: Very clear Yep, you qualified the answer.
• 25:45
  Speaker 2: It depends.
• 25:46
  Speaker 2: You qualified the answer it depends.
• 25:48
  Speaker 2: That was good, all right.
• 25:52
  Speaker 2: So another.
• 25:53
  Speaker 2: This is a hot topic.
• 25:54
  Speaker 2: There's a lot of coverage about this Every conference, lots on LinkedIn.
• 26:02
  Speaker 2: It's the upcoming ICH E6 R3 guidance and the new emphasis it puts on the topic of sponsor oversight.
• 26:07
  Speaker 2: Could you just give us a few highlights from the proposed guidance for our audience members who perhaps didn't look on beyond just the headline that there will be some new guidance?
• 26:22
  Speaker 3: Yes, indeed I can.
• 26:23
  Speaker 3: So with my clinical excellence training academy I provided the GCP refresher based on that revision three.
• 26:31
  Speaker 3: So I've read it by myself.
• 26:33
  Speaker 3: It's not easy to read, so better get prepared and plan some time for it.
• 26:39
  Speaker 3: Because they restructured the whole document and I need to admit the document suffered from the restructuring when it comes to readability, from the restructuring when it comes to readability.
• 26:52
  Speaker 3: On the other hand, until now, with the revision two, we had a proposed risk-based approach in GCP which was not mandated but recommended.
• 27:03
  Speaker 3: With the revision three I got the feeling that you will get inspection findings if you are lacking the risk-based approach.
• 27:13
  Speaker 3: So it's really pressing and forcing the sponsors and the CROs into the risk-based approach now.
• 27:22
  Speaker 3: So we can read some statements like one size fits all approaches are discouraged, the procedures should be fit for purpose and we also the use of resources has been considered system in general, because the quality management system, thinking really broadly here, should be risk-based in future.
• 28:22
  Speaker 3: And there are specific instructions around cloudy sentences around sponsor oversight.
• 28:39
  Speaker 3: Now we are getting more and more concrete.
• 28:41
  Speaker 3: With the revision three.
• 28:43
  Speaker 3: We have a portion about selecting a suitable vendor.
• 28:48
  Speaker 3: We have instructions around how to define the aspects going into agreements.
• 28:56
  Speaker 3: So it's getting more and more granular.
• 28:58
  Speaker 3: For sponsors, what does that mean?
• 29:00
  Speaker 3: To have vendors qualified and overseen and, at the same time, the guideline is giving us more push for adequate documentation and transparency, especially when it comes to the sponsor oversight topic.
• 29:18
  Speaker 3: So in the end, as a summary, I would say there's nothing brand new.
• 29:25
  Speaker 3: Things are getting mandated nowadays, like the risk-based approach and more concrete, like the sponsor oversight and vendor oversight.
• 29:38
  Speaker 2: Got it.
• 29:39
  Speaker 2: I think that's a helpful summary.
• 29:41
  Speaker 2: I think it's probably, hopefully there's positive opinion about the new guidance, albeit the document sounds difficult to read.
• 29:50
  Speaker 2: I guess if the guidance is more specific, that's good in some respects because it gives people, uh, more specificity as to what they should be doing, um, but then sometimes people don't like such specific guidance because it's uh, that means that you're more accountable whenever anything's more specific.
• 30:09
  Speaker 2: So, yeah, be curious to see the the general sort of feedback from the audience, and when's this going live?
• 30:17
  Speaker 3: by the end of this year, so it's expected by quarter four got it all right.
• 30:24
  Speaker 2: um, and I think that's a good kind of next uh discussion point about what a bit about you and your background.
• 30:32
  Speaker 2: So what's got you so interested and focused on this specific topic and then related topics to?
• 30:40
  Speaker 2: Maybe you can give us some of the highlights of your background and career, jessica yeah.
• 30:46
  Speaker 3: Yes for sure.
• 30:47
  Speaker 3: Yeah, I was in touch with vendors all the time.
• 30:52
  Speaker 3: So I started my career with a vendor with a central laboratory and decided to move to a big pharma, driven by curiosity, because they were.
• 31:04
  Speaker 3: You know, as a vendor you often get pushed by the sponsor about timelines, performance, and once you achieve that then probably you get a handbrake and everything is stopped and you can't realize the rationale behind.
• 31:18
  Speaker 3: So I was curious to see how big pharma is working and this is actually where I learned clinical operations, how to plan and conduct clinical trials, initially on a country level for Germany, where I was working as a country study manager.
• 31:37
  Speaker 3: But here again, all the main documents, like the protocol and the functional plans, have been written by the headquarter.
• 31:48
  Speaker 3: The vendors have been selected by the headquarter, the vendors have been selected by the headquarter.
• 31:51
  Speaker 3: So, again driven by curiosity, I wanted to go to the headquarter level to see how things are going there, and that's why I moved to the mid-sized and small biotech scene, working on a headquarter level, working as an international project leader for Clinique Atron, and this is really I entered into from an in-house concept to a full outsourcing concept.
• 32:19
  Speaker 3: So it's really from black to white or from white to black, dependent on how you look to the things.
• 32:28
  Speaker 3: Yeah, and since 12 years I'm working with vendors from the sponsor side.
• 32:34
  Speaker 3: I needed to understand the different business models and how to communicate, how to communicate sponsor expectations and how to track the vendor performance.
• 32:49
  Speaker 3: So it was really my daily business until now.
• 32:52
  Speaker 3: So during the last years I worked up the career ladder to head the clinical operations department, nationally, but also globally, for two companies, so I was overseeing the whole clinic.
• 33:10
  Speaker 3: It's more from the governance level lately, yeah, but still working with vendors and being interested in how we can improve the collaborations.
• 33:23
  Speaker 3: My lessons learned from the last 12 years is most of the time it's either a miscommunication or a lack of communication leading to issues.
• 33:35
  Speaker 3: There is no negative harm on a personal level.
• 33:40
  Speaker 3: Usually there is no error for purpose, you know.
• 33:45
  Speaker 3: So it's just human beings working with human beings and most of the time sponsors have not defined their expectations.
• 33:56
  Speaker 3: Cros might have not communicated their internal struggles.
• 34:01
  Speaker 3: So my my overall try these days being a consultant is helping both ends to work together and learn from each other and make clinical trials happen successfully together as one team.
• 34:20
  Speaker 2: Nicely put.
• 34:21
  Speaker 2: I like your take on that.
• 34:23
  Speaker 2: If I heard what you said correctly, people aren't going out there to do anything malicious, for example.
• 34:31
  Speaker 2: They're.
• 34:31
  Speaker 2: They're there to get a job done.
• 34:33
  Speaker 2: But often some of these challenges are, as a as a result of some kind of miscommunication or the absence of communication in the first place, things falling through the cracks or a point not passed on or something like that.
• 34:46
  Speaker 2: Yeah, I hear you on that one.
• 34:50
  Speaker 2: One point you did talk about, actually in your recent career and you touched upon it earlier in some of the other dialogue we had was around governance.
• 34:58
  Speaker 2: Could you talk to us a little bit about what governance means to you and the importance of good governance structures at an organization?
• 35:09
  Speaker 3: Yeah, for me, vendor oversight is more on the clinical trial level, and this is something where you can clearly oversee the activities and records and data in your clinical trial.
• 35:25
  Speaker 3: What you can't cover by this approach only is any systematic effects right, and this is where vendor governance plays a critical role for me because, as mentioned before, vendor oversight is clinical trial level.
• 35:43
  Speaker 3: I'm looking to one specific clinical trial with one specific vendor assigned to this clinical trial.
• 35:50
  Speaker 3: Clinical trial with one specific vendor assigned to this clinical trial.
• 35:52
  Speaker 3: With vendor governance.
• 35:53
  Speaker 3: I'm looking to one specific vendor still, but the scope of the meeting and the discussions is around all awarded clinical trials, so I can have some kind of meta-analysis between different clinical trials to detect some systematic issues or trends, and it's getting more and more strategic as well.
• 36:19
  Speaker 3: So I'm starting to talk about plant clinical trials as well future products coming to the clinic, right.
• 36:29
  Speaker 3: Um, maybe even aligning on procedures, systems to be used and how to to tackle things together as a collaborator, as one team, right?
• 36:43
  Speaker 3: So it's a little bit above one clinical trial and looking for one vendor over all assigned clinical trials.
• 36:55
  Speaker 2: Got it.
• 36:55
  Speaker 2: That's helpful.
• 36:56
  Speaker 2: And should it be the sponsor that drives the governance, or is it the vendor?
• 37:01
  Speaker 2: Is it collaboration of both?
• 37:04
  Speaker 3: Well, you can compare your question with a family.
• 37:08
  Speaker 3: Would you ask the child how should you get educated by your parents?
• 37:17
  Speaker 3: probably not probably not yeah it's exactly the same, right, yeah, we, as, as a parent, you give your expectations to the, to your children, and, as a sponsor, you should give your expectations to your vendors, because obviously you are assigning responsibilities to them and they are getting paid for it, right?
• 37:41
  Speaker 3: I give you an example I've been through, and it's also tackling the question how to contract with vendors.
• 37:51
  Speaker 3: So I was assigned to a clinical trial which was running at that time already.
• 38:00
  Speaker 3: The setup was completed, so I joined the clinical trial in the middle right and the CRO.
• 38:10
  Speaker 3: So it was a full outsourcing concept and the cro was contracted based on units, which makes sense because you need to define the number of units you need for every activity to come up with your budget, right, um, based on your clinical trial assumptions.
• 38:29
  Speaker 3: So it was a phase one dose escalation clinical trial and we realized, okay, the data have not been entered into the ECF, neither have the entered data being reviewed and source data verified by the CRAs.
• 38:45
  Speaker 3: So we wanted to prepare the data monitoring committee meeting.
• 38:51
  Speaker 3: The CRO mentioned to me we are done and you see, I gave you a real life example before.
• 38:59
  Speaker 3: It was my personal example.
• 39:02
  Speaker 3: So I said no, we are not done because 30% of the data are still missing.
• 39:08
  Speaker 3: And the CRO mentioned to me he never specified which data points need to be in.
• 39:14
  Speaker 3: And they were right as a sponsor.
• 39:20
  Speaker 3: There was no documentation in place which data points to be added.
• 39:26
  Speaker 3: It was just on a panel level, right?
• 39:29
  Speaker 3: So it's like safety data, yeah, but which safety data points?
• 39:34
  Speaker 3: Right, it was not defined after entry whether they should be monitored or queries should be closed or medically monitored.
• 39:44
  Speaker 3: No specification around.
• 39:47
  Speaker 3: No specification around.
• 39:49
  Speaker 3: So we sent the CRA to the site, paying the next units for clinical monitoring.
• 39:56
  Speaker 3: The visit was conducted, we got the monitoring visit report, we got another data extract, but still 20% of the data were missing.
• 40:08
  Speaker 3: So we sent the CRA another time to the site.
• 40:12
  Speaker 3: And we can continue forever, right?
• 40:15
  Speaker 3: So you're paying units and you send the resource to do the activities.
• 40:20
  Speaker 3: You are not getting a satisfactory outcome.
• 40:23
  Speaker 3: So you're resending.
• 40:25
  Speaker 3: You're resending, meaning you're paying and paying and paying and you slowly increase your quality.
• 40:33
  Speaker 3: And that brought me to the point to go with milestone-based contracts, and the milestone should be x percent of data must be entered, y percent of entered data must be source data verified, z percent of data must have undergone the medical data review and only then you get the milestone X, y, z.
• 41:02
  Speaker 3: So this is how I would tackle the vendor oversight.
• 41:15
  Speaker 2: I like it a very real example.
• 41:16
  Speaker 2: That uh sounds like there was a fair bit of pain for everybody concerned and cost too, but some lessons learned as well and milestone-based contract.
• 41:23
  Speaker 2: yeah, that's why we start to see milestone-based contracts probably becoming more prevalent, I would imagine for those very reasons.
• 41:31
  Speaker 2: All right, I really appreciate that background and that example.
• 41:35
  Speaker 2: Now is your time to give us a quick pitch.
• 41:37
  Speaker 2: So, even though we've talked all about vendor oversight, I know that you've branched out and you've started a business helping lots of different people do lots of different things here.
• 41:49
  Speaker 2: Tell us a bit about your consultancy, who you work with and the types of outcomes that people can expect to realize if they work with you.
• 41:58
  Speaker 3: Yeah, thank you so much for giving me that chance.
• 42:01
  Speaker 3: Yes, actually, I started my own business being a consultant for clinical operations, so I mainly work with small companies and mid-sized biotech and pharma companies, helping them in planning and implementing their clinical trials, including the vendor selection and vendor oversight topic, but much more when it comes to country feasibility, site feasibility, creating modern clinical trial design, setting up systems.
• 42:32
  Speaker 3: So it's really various activities I can help you with, but at the same time, for very, very small sponsors, I'm also able to help in creating the SOP framework to get the robust basis in place to even start the planning and implementing of their very first clinical trial, and also helping in building their clinical operations team.
• 43:00
  Speaker 3: This is something I've done two times now on a global scale writing the job descriptions based on this, the defined outsourcing model, helping interviewing candidates, bringing them on board and getting them trained, either with live trainings with me as an instructor or, as mentioned before, via the clinical excellence Academy, where I'm providing digital training courses.
• 43:31
  Speaker 3: So that's me in a nutshell.
• 43:34
  Speaker 2: Fantastic Sounds like you wear a lot of different hats, but there's a lot of requirement for the services that you outlined.
• 43:41
  Speaker 2: I'm sure of that just based on conversations that I have.
• 43:44
  Speaker 2: So I expect you to get many calls from listeners who are looking to engage with you in that context.
• 43:50
  Speaker 2: What we always like to finish on with this podcast is a final question, and that question is if you could wave a magic wand and change one thing about our industry, what would that be and why?
• 44:06
  Speaker 3: Okay, so I'm a people person.
• 44:11
  Speaker 3: That's why my answer is I would like to improve the willingness to listen and understand to each other, including sponsors, vendors, sites, patients, regulators.
• 44:30
  Speaker 3: As mentioned before, I have the feeling that most of the issues we are seeing in clinical trials are having the root cause of miscommunication or even a gap of communication.
• 44:45
  Speaker 3: So, thinking about patient centricity, I would love to see that people are trying to improve the way they are working together to bring that drug faster.
• 45:01
  Speaker 3: It comes to requirements, to feelings, to constraints and working together as a team amen, I love it.
• 45:20
  Speaker 2: Sometimes, like the, the responses that we get into that question can be very kind of niched and technical, but yours is like back to the foundations, of sort of first principles really, and I think that's a fantastic way to answer that question and to end the show.
• 45:38
  Speaker 2: Before we drop off, though, I know many of our audience members are going to want to learn more, so where is the best place for them to get in touch with you if they do have questions or indeed want to speak to you about some of the services you offer?
• 45:53
  Speaker 3: you'll find all informations on clinical minus excellencecom, or you can visit my linkedin profile where you can also book-t-aclinical-excellencecom, where you can find the Clinical Excellence Training Academy.
• 46:20
  Speaker 2: Jessica, this has been excellent.
• 46:21
  Speaker 2: Thank you so much and really looking forward to engaging with you in the future.
• 46:26
  Speaker 3: A big pleasure from my end.
• 46:28
  Speaker 3: Thank you so much.
• 46:51
  Speaker 1: You're listening to Transformation in Trials.
• 46:53
  Speaker 1: If you have a suggestion for a guest for our show, reach out to Sam Parnell or Ivana Rosendahl on LinkedIn.
• 46:59
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