CRO partnering with Veeva eTMF

Doug Bain, Chief Technology Officer at KCR

I had the great pleasure in speaking at the Veeva EU R&D and Quality Summit in Zurich 8th June 2022 together with Ruth Ruffieux from Alvotech and Mellisa De Swaef from Argenx.

One of the challenges we face when running a clinical trial is the management of documentation. This can be an extensive (and expensive) activity that has a high level of regulatory scrutiny. Today, we have tools such as Veeva Vault Clinical (VVC) eTMF that assist in the processing and filing of documentation.

A question that our session at the summit attempted to tackle related to the appropriate use of the software by each organization. Should the eTMF software be licensed and controlled by a Sponsor, by a CRO or a hybrid combination of the two.

Where should the eTMF be?

KCR have used Veeva Vault Platform since 2014 and Veeva Vault Clinical eTMF since 2019 for the storage of TMF materials. Our implementation has been evolved and enhanced over the years. Today, we release updates to the platform and our configuration monthly.

Today, we define for all our clinical trials, amongst other configuration settings, a set of Expected Documents (aka EDLs) within a set of study milestones. The progress of the receipt and processing of documents within these milestone are a good granular indicator of whether the study is on track and inspection ready through the lifecycle of the trial. Without this level of granularity and the nature of patients being at different stages of a trial based on their recruitment date, it can be difficult to obtain a true reflection of the health of the documentation of a trial at any one time.

At the same time, sponsors may wish to hold their own set of documents in their TMF. To do this they may not need the level of detail in the Milestones, EDLs or additional document metadata that the CRO does, however, they do wish to combine their documents with the documents from one or more CROs.

A CRO can proceed with the use of their own configuration of VVC eTMF supported with the highly granular KPI’s driven by Milestones and EDLs. By leveraging the TMF transfer utility, the materials loaded, reviewed, and filed by the CRO in their own VVC eTMF can be transferred during or at the end of the trial to the sponsors eTMF.

This Hybrid approach ensures sponsors have the best possible oversight of the progress of the documentation for the clinical trial while also receiving a ‘validated’ copy of all the materials at the end of the trial.

Near real-time dashboards present the information the sponsors need to achieve oversight. In some regards this is preferential to sponsors holding their own eTMF — having the documents does not necessarily guarantee oversight is achieved.

Implementation optimization

Each organization would like to feel that their particular software implementation is fully optimized with associated processing and training in place to ensure it functions to its best. The reality is that both CROs and Sponsors go through an improvement evolution lifecycle. For cloud platforms like Veeva, users work off a base framework to eventually reach a fully optimized implementation. In our experience at KCR, this can take anywhere from 12 months to a number of years. The metrics below show a snapshot of one of the Key Performance Indicators that we maintain. In this instance, it is a high-level roll-up KPI that shows the relative document complete performance based on the use of Veeva Vault Clinical eTMF versus the legacy Veeva Platform Platform versus sponsors Veeva Vault Clinical eTMFs.

KCR use our 8+ years of experience in leveraging Veeva Vault for managing electronic Trial Master Files in not only providing an optimal inspection ready eTMF solution but also in providing consultative advice to sponsors that wish to setup their own solution.

Postscript — optimizing the eTMF solution

A question was raised following the session. Why might Sponsors and CROs work in their own copy of Veeva and the eTMF — why don’t we have a single eTMF that we all share for each trial?

My answer below is more from my opinion as a software designer.

When you run a clinical trial you are required to prepare a single Trial Master File. Historically, a TMF has consisted of individual materials from each site and CRO . So, for example, if you, say have 50 sites, 2 CROs and 1 sponsor for a trial, you effectively start with 53 ‘locations’ for documents.

When working with a cloud platform, in principle all users are able to use the same system. The rules regarding separation of sites, CROs and Sponsors need not hold.

Unfortunately, we are working through a lifecycle of evolution when it comes to using cloud platform technologies. Currently, each organization has their own definition of a clinical trial, and. the materials associated with it.

Interfaces are created between the organizations and therefore between trials and between TMFs. For Veeva, we have Site Vault where sites can store their materials. Site Connect provides functionality to transfer the documentation to the CROs VVC eTMF. We then have eTMF transfer to transfer the CRO eTMF to the Sponsors eTMF.

To change this in the future the eTFM solution would need to be extended to function fully for multiple organization and roles with a user experience designed for sponsors / CROs and site staff. Correspondingly the processes that are followed for a single trial would need to be baked into the platform. The most challenging change though would be to have all parties work in a single location (or Instance). The principle of all parties working with a ‘trusted 3rd party’ that can independently host a trial (and the eTMF) is not yet established. Companies like Veeva would need to provide a service to oversee the definition of the study and assign organizations to this allowing each party to be able to contribute materials to the study (eTMF) based on their organizational and functional Role(s). This approach would allow each party (Sponsor, CRO, Site and others) to effectively maintain their own set of materials and ‘publish’ (i.e. make visible) as the appropriate time according to appropriate workflows.

So — in summary, although the idea of silos of eTMF materials existing today, the ability to define and transfer materials between CROs and Sponsors is a viable option for many situations.

This article was originally published on LinkedIn on June 16th, 2020.

About KCR:

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston, US, Berlin, Germany, and Warsaw, Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.

We see the human behind every number.

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KCR CRO

KCR CRO

KCR is an international clinical development solutions provider for the bio-pharmaceutical & medical device industries.