In this session, Kivo CEO Toban Zolman and SVP of Clinical Marion Mays outline the best information technology practices for accepting, managing, and storing trial master files, particularly following a transfer from a CRO.
Key topics for the session include:
- Creating a TMF transfer plan
- Compliance gaps to avoid when moving a TMF
- What inspectors look for when reviewing a TMF
- Factors to consider when archiving a TMF for long-term storage
- How Kivo approaches TMF transfers
- Things to look out for from a technology perspective
Watch the full session or view the entire transcript below. For help with an upcoming TMF transfer, don't hesitate to reach out to our team.
Full Session Transcript
Toban Zolman: Hi, everyone. Welcome to today's webinar on IT best practices for receiving ETMFs from CROs. My name is Toban Zolman. I'm CEO of Kivo, and I'm joined today by Marion Mays, our Senior Vice President of Clinical. Marion, if you skip ahead to the agenda, I'll talk through what we've got teed up for today.
Marion will start talking through moving your TMF from CRO into a sponsor-based system, look at the compliance gaps that happen as part of that, how end of study transfer works, and then finally wrap up with some keys to success. I'll be layering in color commentary as we go on some of the technical pieces to look out for and share how Kivo approaches this from a process standpoint. So that's where we're headed.
We'll take a second and do some formal introductions. I appreciate everybody joining us today. Marion will be kicking things off this morning. Marion is our Senior Vice President of Clinical at Kivo and has over 30 years of experience supporting a host of organizations through trials and inspections with regulatory bodies all over the world. Marion has worked for sponsors, worked for CROs, and worked for software companies, so she's seen the challenges from every angle and has some great insight that she can share with everyone today.
My name is Toban Zolman. I'm CEO at Kivo, and I've spent a lot of years working on business process and technology in life sciences, both on the regulatory side and now on clinical and quality as well. I'll talk through some of the technical pieces that we see with TMF transfer and how we approach that at Kivo and work to solve that on behalf of our customers. So without further ado, I'll turn things over to Marion and we'll get going. Marion?
Marion Mays: Thanks, Toban. I appreciate it. I'd like to start us off with a poll just so that I can better understand our audience and see where everyone is at. Are you getting an extract from your CRO here soon? Maybe you don't really know. Maybe you know it's going to be at least a year or so.
Looks like we've got pretty good results, so I'm going to go ahead. Within the next three months, looks like about 33% of you expect something here pretty soon. So this is probably a timely webinar for you to listen to! Six months - it'll give you some time to plan for it in the next year, good time to put some good processes together. Then in the next two years - hopefully we'll give you enough insight that you'll be able to really utilize the information and put some good processes in place. I have stopped that poll.
Let's talk about moving your TMF from your CRO. There are a lot of pieces to it. Your study is closed.You collaborated the entire time with your CRO. They were running your study. They were collecting all the documentation. We know that it's more than just the TMF. There's the safety and the data management and the stats...all of this is super important documentation. So when we talk about end of study transfer, even though we really focus a lot on the TMF, I just like to remind everybody that it's not the only thing that needs to come over from your CRO at the end of the study.
A lot of things that we're going to talk about really do apply to not just the eTMF, but also to your data management activities and data sets that come over with that and all of your safety files. As a sponsor, this is the evidence of your trial. This shows what happened during the trial. It is story of your trial. In order to get regulatory approval, you need to be able to share it with them.
With that, what is it that you're doing at the end of the study? How are you receiving it from your CRO? And the big thing is, do you have a plan? Have you mapped out how this is going to happen and how is that handover going to happen? Because remember, one of the big things in GCP is the chain of custody of information and documentation. So let's talk a little bit about defining the process and what needs to be included in that.
First of all, you need to define what's going to be moved, where is it coming from and where are you going to put it. Make sure that where it's coming from, obviously, is a controlled system, and where you're putting it is a controlled system. What are the workflows? How is this going to happen after you get it? How are you checking it, making sure that you have everything? Did you get everything? When we talk about TMF completeness, a lot of times during the study, we're trying to see completeness. Do you have what you need at that point in time? Did you get everything that you're supposed to? Do you have all the documentation? Can you recreate everything that happened during the study? Have you standardized that content so it's easy to navigate and understand where things are and how they're stored? Because during inspections, you don't want to have to try and figure out then when or where the documentation is.
So with that, I've got another poll. Do you have a plan? Do you have an archive? If it's not archived, are you putting it into your eTMF system? Are you going to leave it with the CRO? And so I always ask people, if you're going to leave it with the CRO, how long are you leaving it with the CRO? Are they going to own your data? How are you going to deal with that?
It looks like we have two big buckets here. People either have an archive system that's already been validated or are in the process of trying to figure out where they're going to put it. So they may need a place to put it. Remember as you're trying to figure that out, the important part is that that system needs to be validated and inspectable.
Let's stop sharing and move on to the next part of this. I always like to remind everyone of the compliance gap. This comes from Andy Fisher. If you're been in a lot of inspections, he's an MHRA inspector. He's very vocal and very focused on the TMF. If he's ever on your list of inspectors, be prepared to be able to explain everything and anything about your eTMF. What he does see is that there is this gap, right? The CRO actually runs the study, and then at the end of that study, the documentation is being moved over to the sponsor, and there is this gap in the middle, because people don't plan for that in between.
They either are taking it and putting it directly into an archive system, and then once into that archive system, they then struggle to provide a good flow of review for the inspectors. What are you doing to make it easier for the inspectors to actually be able to review that documentation and consume that documentation, and especially during that interim period? Where are you putting it? Is it still going to be inspected? Or do you already have full approval on your product, therefore, yes, it actually could just go into your archive. So these are all really important things to consider so you don't find yourself in this inspection gap or compliance gap.
So the end of study transfer considerations. There's really a difference between your long-term strategy to manage the data and to keep it compliant for a number of years. A lot of people say, "so what? According to the ICH guidelines, I only need to keep it, like, two to three years after the study is over." Well, no, not really. If you don't read all of the regulations that go along with it, yes, the study is closed, and yes, it's only two years, but, oh, by the way, if you have this component, you have that component to it... if there was any safety that was collected or anything like that, all this needs to be kept longer than that.
Then if you've done trials that are outside of the US in any way, then you have a much larger burden of extensive time that you need to keep these studies. In Canada, that's 15 years. In the EU, it's at least 25 years. Then when you get into APAC, it's significantly longer than that. So you really need to take that into consideration when you're actually getting ready to transfer your information.
The other thing is, is your CRO supporting you during your inspection? Even if you take it back at the end of the study and you haven't had your inspection, is your CRO going to support you? When you put it into your system, you're going to need to be able to grant access to your CRO in case they're actually interviewed or something like that, and need to share the information with the inspectors. Granting access and who needs to have access and how you're going to do that.
How are you documenting that transfer? Do you already have an SOP in place? Have you already laid this all out and is it well documented how you're going to do this? What is the documentation that you are creating or having after that transfer is completed? We talk about checks and making sure that everything moved over. How are you documenting all of that? This all leads to data integrity, that it was well managed, well controlled, and that the data is safe and sound as it moves over.
So, the end of study. I always tell people, in this journey that we're all in going through the trial conduct, what is it that we're really trying to achieve? I think all of us are trying to achieve a successful inspection, which leads to a successful launch of the product or device or therapy. That's what we're really trying to accomplish - to bring treatments to patients who need them. The only way that we can do that is to make sure that we're keeping good track of our documentation. An eTMF system obviously helps us attain that goal, but also the checks and balances when this actually moves. Keep track of where your data is and that the content is residing in a place that is able to be qualified and that shows that you had control over it, especially since there's so many different systems that are involved.
So you've got your eTMF and all those other systems. Are you consolidating? And when you're consolidating, have you thought about the constraints that you might have based on the systems that were used prior to that? Are you able to have the audit trail that comes along with those other pieces as well? How are you going to show due diligence during your inspection? That you had good control? What do you need?
Consider how you're going to manage the flow of all of this information, especially the audit trails. Along with the eTMF, the content and its audit trails, let's think about how we're going to move the safety content, the data management, including your CRFs and DCFs. A lot of this is all electronic. A lot of us have moved to the digital world. At first we think that that just makes everything so much simpler and easier. It becomes more difficult to ensure that you have good integrity when that data moves from one place to another. The stats, and medical writing, the CSR, your protocol that might have been written by your medical writing team, and then the regulatory information.
A lot of times when you're doing multi-countries, there is regulatory that's spread out through different areas and different systems. Especially if you've subcontracted that out, it's important that you still bring all of that back in-house and that you have good control over your regulatory approvals and your regulatory submissions.
Our ultimate goal really is our inspection. We want a successful inspection. How are we going to manage that after we have transferred everything, how we're going to grant that access, how we're going to show good control over that? It's important you can document all of this in an SOP. If you plan on doing lots of them, that makes sense. Otherwise, a migration plan is one of the critical pieces. You'll want to be able to have that compliant enough to be able to put into your eTMF so that you can actually share that with the inspector should they have any questions about how the migration activities actually occurred.
The inspectors are going to want to know what was the original system of record, what is now the system of record. They want to have access to the full audit trail. They want to know what happened from the very beginning to what happened after it was put into the new system. How were they controlled? How did they move from one place to the other?
Then the next step really is your long term storage. How are you going to do that? Like I mentioned before, that 25 year mark can be daunting for a lot of us, and a lot of us have moved to the cloud. So how do we manage the cloud data after it's been put in the cloud? How do you make sure that it stays in a state that's accessible? What are the checks that are being run? What's the security around all of that? Records need to be maintained in a way that they're still accessible and that they can be inspected throughout that 25 year time frame. Even if you put it in your archive, which is great, are you able to share that with an inspector should they come back and ask? Especially for those compounds that sometimes we build upon in the pharmaceutical world.
We have the multiple dosage. How are we going to show from the very beginning, from the very start of the trials, how that all came together? They may want to look at that. How are we going to share that with them? In your archive, what is the type of audit trails that exist? What are the checks that you're doing, how often and all of that. The requirements around individuals who manage this...are they qualified? How are they checking on the activity that's happening? You need to have named individuals that are doing this, a specific role that does this. And obviously all of that transfer and how are things are being managed and maintained, because they want to know if there's any alteration or changes, especially if you're moving from system to system. If you do decommission, what is the decommissioning plan and what is it that you did in order to ensure the transfer ?
One more quick slide before I move on to one more poll on eTMF long term solution. This is kind of the way that Kivo looks at archives. We're controlling access so that not everybody has access and it should be read-only access, and that only those who really need to have access to that information. You should be able to grant inspection ability. Anybody who might be doing an inspection, granting them access, regardless of the health authority that asks for that. The audit trails capture any activities. Who's gone in there and touched that file during the time period? Are you checking your files regularly? Whether quarterly or at least once a year to make sure that there aren't any files that are getting corrupted through any system changes or anything like that? Is it in an archival format? I don't know about you, but if I had to open a word perfect document, I don't think I could. We need to make sure, right, that whatever format it is in archive, that we're able to open it up.
So with all of that,I would like to ask everybody, are you ready? Can you do this? We would really like to be able to support people through this. Have you planned for this? Have you thought about how you're going to do this? And if you are going to be working on [a TMF Transfer], hopefully I've given you some good places to start, some things to think about and consider when you're doing this.
It looks like, Toban, that we've given people some things to think about. It looks like some people are on target and ready to go with their transfer plan, but some people look like they're going to be working on it. So that's great.
With that, I'd like to turn over to Toban and give him the opportunity to talk about how technology can help you with all of this. Toban?
Toban Zolman: Thank you. Thanks very much. What we really wanted to focus on in the second part of the webinar is really get into the nuts and bolts of how this happens.
Marion did a good job of laying out kind of what the considerations are from a process standpoint, from a regulation standpoint. We want to really look at that intersection between process and technology and how we run these TMF transfer projects at Kivo. Through the school of hard knocks, we've figured out where there are gotchas and how we can leverage both process and technology to solve a lot of these. So this is the landscape that I'm going to talk about.
We're going to start by looking at how we do controlled transfers, how we do the import or migration into Kivo, how we conduct QC on that, how we then manage that TMF during the final part of the trial, receiving documents that are slow to come in from investigator sites, ultimately run the virtual inspection in Kivo, and then move documents into long term storage so that you can handle the archival portion. We're going to tackle all of that here in short order.
Let's start with the controlled transfer. This is actually a really big thing, and if you walk away from this webinar with one piece of information or best practice, I hope that it's this. The reason is we predominantly deal with emerging companies, smaller life science firms that have leveraged the CRO to run a clinical trial or clinical trials, and they gloss over the importance of this transfer. When we start to engage with a lot of customers, they are already in possession of the TMF, and that is frequently not in any sort of a controlled environment. So right out of the gate, you have compliance issues and are starting on the back foot, trying to process SOPs and generally try and very quickly move that TMF from however you got it - a thumb drive, a CD - into a controlled system.
Let me share just a couple of stories of how quickly this can become problematic.
We've worked with a customer who received a study on an encrypted thumb drive. They physically sent the sponsor the thumb drive, and then in parallel emailed the head of clinical at the sponsor the encryption key. Time passes, that person left the company, their email was destroyed, and along with it, the encryption key for the thumb drive. The CRO also destroyed the data per the contract. The contract ended, and so they destroyed the data. And so the entire clinical trial was caught up on an encrypted thumb drive that could not be decrypted. So that's obviously an extreme example.
Ultimately, what we see time and time again is CROs want to get out from under that TMF as quickly as possible at the end of a trial. They will dump it on an FTP site, transfer it via Box, put it on a thumb drive, burn it on media, whatever it is. And once you take possession, they wash their hands of it and move on. If you don't have a migration plan in place at the time you receive that file or receive the TMF package, then you're immediately in some form of compliance risk. So at Kivo, it's super critical that we work with our customers to define that plan before the end of the trial. What we do from a technology standpoint is we've eliminated all of the thumb drives, all of the zip files on an FTP site, and instead we've built a connector where CROs can load the data directly into a controlled environment in Kivo. From the second it hits that environment, everything is controlled, covered by an audit trail, and it radically simplifies the compliance risk and it streamlines that entire handoff.
Comparing the migration plans that we're able to run with our customers using this sort of a mechanism versus what they're doing with things that have been sitting on a file share that it is managed for an unknown amount of time. It greatly simplifies all of that. Reduces the scope, takes pressure off of the SOPs and migration plan and just frankly streamlines the entire project from that point forward.
From an IT perspective, we end up talking to a lot of IT directors that have no context for any of these compliance complexities. They have somebody from ClinOps that comes to them and says, "hey, I need a file share to drop this study".They will immediately spin something up, give them access, without really understanding the long term implications of that. So the first thing I would really point out is make sure you're ahead of the curve when it comes to managing and taking control of the TMF.
Next, Marion, if you advance, I want to talk about the import process for TMF transfer. One of the things that we have seen as an industry trend is that the transfer of data from one TMF system into another is generally not managed in a super effective way. You may have rich data that the CRO had wrapped around a TMF through metadata, audit trails, version history. Let's say they're using Veeva to manage the study. When it gets transferred to the sponsor, that gets spit out into zip files and binders at the study level, the site level, study level. The sponsor has to make sense of what to do with that because you essentially have the files and the context of those files, the metadata audit trails, et cetera, as separate objects, as CSV files typically.
Managing all of that data and reconstructing it in a way that will make sense downstream - and when I say downstream, I mean two or three boxes down. This process chart to inspection is really critical. Let me share a little bit about how we tackle that with Kivo. From a technology perspective, my hope is that you have context for that, such that even if you are not using Kivo, you can adopt some of these best practices into whatever system you are using.
The first thing is really mapping all document metadata. So the challenge we've seen here is, let's say you're going from, I don't know, Wingspan to Veeva or using an EMS standard in between two systems. It doesn't really matter, and I'm not picking on any one vendor. But whatever that path is between two systems, if both systems don't support the exact same metadata structure, then inevitably what we see happens is important metadata gets dropped on the floor during the migration or it gets stashed in a related file that an inspector would have to dig through. It's not formatted well. It's like a CSV. So it's really hard to reconstruct both mentally and visually in the app exactly what happened with a file or with a document. We've built on the receiving end of Kivo the ability to preserve all metadata, even if it's not mapped into a metadata field, that is relevant and important in Kivo to how we've implemented the TMF reference model.
If there is system specific information that's coming from another vendor system - rendition information, audit trail information - all of that shows up in Kivo and is still viewable. It's just below the fold, so to speak. It appears below the rest of the key metadata in the system. So first and foremost, really try and preserve all metadata, and preserve that in a way that an inspector can actually make sense of. Part of that is audit trails. The way most systems handle audit trails is you have the file, maybe the rendition of it, and then you have a separate CSV for audit trail. It makes it really cumbersome if you're an inspector to have to navigate between the audit trail that's in the viewing system you're using and then drop into a CSV to make sense of other history information.
What we do at Kivo is we actually have the ability to parse audit trails from other systems, and we inject that into the Kivo audit trail. So when you're viewing a file, if you jump over to the audit trail, you can see every action that happened in Kivo and then every action that happened in whatever the other system was, Veeva or anything else. That provides a richness of context as that study has moved from system to system and from CRO to sponsor to bring the right context and right data to the forefront.
Then the final thing is being able to maintain both source and rendition. One of the issues we've run into with customers is that what they receive from the CRO doesn't have any of the source documents, it just has renditions. So if they need to do any maintenance of that study as additional stuff comes in or to update anything, they have no source files in the system to do version control.
With Kivo we're able to maintain both the source and the rendition of every file, including if you're doing redactions, which is relevant for studies in Europe that are going into the CTIS portal. We can handle all of that, and keep all of that data stitched together. That's a really key part to ensure that A) you've got a controlled transfer, B) when you import that into the system, you have the richness of all of the history of the trial.
Then it moves us into the next stage, which is QC. Studies can get very large very quickly. Let me make one other point here before I talk about QC, and that is not all exports are equal. This is something that is a constant challenge for us and can be massively problematic for sponsors that are not immediately importing data that they've received from their CRO.
Let me give you kind of a war story here.
We're in the process of importing or migrating, I don't know, somewhere around 15 studies that are all coming out of a single CRO system and coming into Kivo. Theoretically, as far as the sponsor knew, all of those studies had originated in the same TMF system and should export in exactly the same way. For us to process what we were able to identify very quickly is out of those 15 studies...a small handful, maybe four or five, didn't actually come from the system that we thought they were. They were sitting there, but they had been migrated into it. So they had a totally different structure, different metadata, and couldn't be processed or parsed in the same way. In addition to that, the studies that they were exporting...the way that most systems work, when you export a study from the TMF system, you have to specify everything that gets exported, what the data structures are, columns and the manifest, et cetera. That's typically a manual process.If you don't get all of those settings the same from export to export, you're going to end up with documents that are missing, potentially.
Let's say you have documents that apply to multiple countries or multiple sites. You could accidentally omit those depending on how you generate your study binders. What we've ended up with from this particular project is just really a grab bag of differences from study to study and even site to site within those studies and have had to go back to the CRO probably half a dozen times for them to kind of get their act together in terms of how they are generating this content, so that everything follows a format where the sponsor isn't losing anything. In translation, we work with a lot of customers who previously received the TMF from the CRO. The CRO has since destroyed it. While they have had it in their possession on a file share for the past six months, what they haven't realized is that there isn't data consistency between the various export files and when they go to import it in, we find that the content is missing, content is duplicated. We have to treat each export as a bespoke element. It's very challenging.
Our guidance is, first, be aware that just because everything's coming out of one system, that doesn't mean all those exports are going to be equal. It doesn't mean you know where those studies originated. CROs shift the TMF management software they're using frequently. It's very common, (shockingly to me at least), common to see what percentage of studies that come into Kivo maybe started in Wingspan, went to Veeva, and ended up in some other system. It's very common for those TMF systems to get swapped out by the CROs. Be aware of this, really pay attention to it.
Build some rigor in with your CRO on how they are exporting this stuff and let us know where we can help in verifying those structures and helping make sure you don't walk yourself into a dark alleyway six months after receiving the study. So not all exports are equal.
Let's talk QC. Studies can get very large. So at Kivo, we really do a dual approach to QC. First we do an automated comparison between anything that comes into the system, so we're able to essentially parse the manifests that come from other vendor systems. We use that to generate statistics about how many documents, how many audit, trail entries, how many versions...all the standard stuff you would expect, how many folders, and then run those same reports in Kivo to ensure that everything matches up exactly. That's like our baseline. Typically we discover, I don't know, 99 point, some repeating number of issues purely through automated comparisons. It's very rare that when we move to manual QC that we discover any real issue with the content. That automated comparison is literally comparing source and destination.
The other thing that we're doing in an automated way is trying to detect any document corruption. So we're looking for documents that are encrypted, documents that are 0 KB documents that can't be opened, maybe they have the wrong file extension...really doing as much automation as we can to detect issues in a rapid fashion. This gives us the ability to migrate a study that's, let's say, 100,000 documents and both migrate it, map it and do this automated comparison typically in about one to 2 hours. That's a massive efficiency gain in this process. To really sanity check where something is at, we can iterate through that repeatedly and go back to the CROs same day to give them feedback on where we see any issues. Then the final piece that we do is a manual verification based on a sample percentage of content - depending on the study and the SOPs for the sponsor between 1% and 5% - to verify that the documents are in the right location. Is it the document that we think it is, the metadata is correct, the audit trail entries aligned, what was in the source system, et cetera.
Really between these two approaches, we're able to A) process a ton of studies in a very rapid way and B) do that with a really high degree of accuracy. We do all of this in a sandbox environment. We capture all of the migration settings that we use and then rerun this again in a production environment. That initial migration and manual verification typically takes significantly longer than when we do it in prod, mainly just because we have everything fully dialed and can rerun that automated comparison, make sure nothing happened technically, and then do the proper 1% QC of the documents. That has worked really well for us. So that's our QC piece.
Let me talk about management. We look at this in two ways; managing content and managing access. This is less about the tech and more about the process, if I'm honest. But I still want to highlight what we do here. The first is we want to be able to manage missing content, safety information revisions, anything that's received post-study by pulling it into Kivo and having it in a proper eTMF system. It gives us the ability as that data flows in, after the CRO is handed it off to us, we have a system to layer that in, make sure the TMF is complete, and have all of that in a controlled environment. As it happens, we have found this super valuable. Instead of having this locked away on a file share somewhere, have it in something where you can easily find and view documents.You've got full searching, you can search across the document metadata, et cetera. It reduces the amount of management overhead over time and frankly increases the quality of the TMF when you don't have content accidentally being copied in, being duplicated, things of that sort. And
The final piece is really leveraging all of that to distribute documents and data throughout your organization or to other partners, sponsors, CROs...whoever you are working with.This is another area where I've been pleasantly surprised with the added value of having a proper TMF system to move this stuff into at the end of the study, because everything's there, it's easily accessible. Then when it comes to inspection, you don't have to move it yet again for them to have access. Giving inspectors controlled access to the TMF is critical.
I describe Kivo's eTMF product as a post-pandemic product. We built and released our TMF product post-COVID, which means we baked into it from day one the assumption that virtual inspections will happen in Kivo. So we've defined a specific user role for inspectors where you can add an inspector to a study, invite them, and they can have access in literally minutes. We hide draft documents for those inspectors, we identify effective dates on approved documents so that it's very clear, for example, with like a protocol, they can see exactly when that protocol was effective throughout. Then we also identify documents that are missing by using placeholders and identify what other system of record that document may exist in. Either it's available with the CRO or it's in a different data system that you maintain. Really stitching together the narrative of the study to present to inspectors has gone a long way.
Like I said, I don't know that from an IT perspective that we are necessarily doing anything radically novel there other than baking this in to the product from the ground up. But I think the important thing to understand from an IT perspective is, all of this is coming once you receive the study, you will eventually need to be able to give an inspector access to view and review that study. Having it from day one in a controlled system that you can give them access to that structures out the entire history of the trial is super critical.
The final piece here is archival. This is another area where we've taken a technology-first approach to how we solve this. One of the challenges, I think, with maintaining documents of any sort over a long period of time is ensuring that there's data integrity. Marion spoke to this. What we do at Kivo is really everything on the screen here. We try and tackle in one shot. When the study is in Kivo, you've received everything and you're ready to close it, you literally click "close study" in Kivo. We rip out all permissions, we lock every document, we set permissions to read-only, we prevent any other permission from ever being applied to that study. We write into the audit trail for every file that it's been closed and what the action is. Then we key that up into a queue where we run data integrity checks against that study every single quarter.
Our intent with that is, if for any reason a file became corrupted in storage, over time, we can drop back to backups within that 90-day window and replace the file, rerun the data integrity check and ensure that over the duration of that storage that you're able to maintain all of those files and nothing becomes corrupted. To Marion's point earlier about Word Perfect files and not having the ability to maintain those, that is a consideration I think that you should have prior to archiving a study, ensuring that you have documents in a file format that supports long term storage, if not full archival.
So soup to nuts, that's how we look at this, really managing things from a controlled transfer all the way to archive. And here are kind of tips or lessons learned from us at a project level for making this happen.
The first thing is to really define clear roles and responsibilities with your CRO. It is surprising to me how often there is not a clear understanding with the sponsor with the CRO on who's doing what and who's on first and how that transfer is going to happen. Very rarely do we see that defined in contracts beyond just "there will be a transfer within 30 days of the end of study."
On our transfer projects, we typically volunteer to be on point so that there is a clear owner that understands the process and the technology to make it happen, and happen correctly. The second piece is to ensure you've outlined how it will be transferred. Again, if you take away anything from this take away, do not accept the thumb drive or the CD-Rom. Establishing the process will also help ensure your transfer goes smoothly and that your CRO knows what you expect the final deliverable to be. Marion gets involved frequently with reviewing contracts and helping then fill in the gaps that aren't in the contract on how that handoff needs to happen.
Prepare to have some difficult conversations about timelines, quality and response to queries. This is an area that I feel like holistically - and again, not pointing fingers at any one CRO - but that CROs are weak. They can run trials effectively. They don't always really understand the nuances from a technical standpoint of getting a study handed back to a sponsor.
Then the final piece ensure you've got a validated and compliant system for storing your study content. We see this frequently where clinical comes to IT and asks for a place to put stuff. IT doesn't really understand the implications of what they're being asked to do and creates a location that kind of jeopardizes everything because it's uncontrolled, it doesn't have the right permissions, has no audit trail, and there's no way to demonstrate what happened to that study in the 18 months it said on a file share with full access to everyone in the company. So that's kind of for us where the rubber meets the road on these TMF transfer projects and how we've attempted to tackle that between process and technology.
Marion, I'll let you take back over and talk about keys to success. Again, if you have questions, drop those in the Q&A and I'll moderate those in just a couple.
Marion Mays: Again, begin with the end in mind. We're all trying to get approval. Part of that is being able to show due diligence, show data integrity, and mae sure that things are done in a way that is easily demonstrated. Start with the beginning and make sure that you're defining your deliverables in your contract. As Toban had mentioned, there have been many times when I look at contracts for some of our clients and some of them, believe it or not, don't even talk anything about the transfer and don't even talk about those 30 days. So I always ask, so what's happening with your data? It's your trial, it's your information, and it's what's going to get you your approval or not. Maybe you should consider putting something in here. So that's where we talk about establishing a plan.
If you decide that's where you want to put it is in your TMF plan, I think that's great. But make sure that you're putting all the pieces in. Not just that it's going to be transferred at the end of the study, but how it's going to be transferred, who's going to be involved in that transfer, and what the expectations are. Where is it coming from and where is it going to and how that's all going to happen. Establish the reporting requirements as well. What are the checks? How are you managing all of that during the transfer? How are you showing that control overall?
The other thing I would highly encourage everybody to do is work with your vendor. It's amazing. I'm sure that you talked to some of our clients when they said, "well, I don't know what to do about this". The CRO says, I don't know what to do with it. And Kivo - fortunately, because we've got a great tech team - that we can say, "we could do this, and this is how we show due diligence, and this is how we can control the process". You'd be surprised the talent at your CROs and at your vendors that actually can help you get through some of the challenges that you may face, so I encourage you to work with them.
My last thing is, remember that the TMF is the evidence of your trial. This is where it all sits. Once the trial is over, your CRO is going to move on to their own other contracts that they have you as the sponsor. This is what you have left. So please consider the valuable asset that it is.
Toban Zolman: Well, we're at time, everybody. I appreciate everyone sticking around and joining us today. If you have other follow up questions, don't hesitate to reach out. Best of luck as many of you are starting TMF transfers in the next six months. Thank you, and let us know if we can help genuinely, in any way. This is what we do day in and day out and we enjoy the work.
Have a great rest of your day and weekend, and thanks, everyone, for joining. Thank you. Bye.
