With this blog article I am taking a closer look at how CRO Users and Activities are managed in Veeva Vault Clinical and deal with decision-making re: who from CRO can/should have access to eTMF/CTMS in Vault, what activities are performed in Sponsor vs. CRO eTMF, and how you can tailor the system according to your needs to avoid functional overload. In my next blog I will talk about Inspection Readiness – “Managing CRO and Sponsor Compliance in Vault Clinical” and part three will cover the topic of Integration and Reporting – “Data Discernment – A simplified approach to strategic planning.”

 

Moving to a cloud-based eTMF and/or CTMS is a big step, particularly for a small to mid-market life sciences organization. The budget to secure and implement eClinical technology typically coincides with a strategic shift by company leadership, often leaving clinical teams feeling pressured to support visibility and engage deeply in a new system. A key challenge is balancing the existing outsourcing model (spend, system integration, and study activities) with the capabilities of the new system(s).

How to find the right balance of streamlined configuration and intentional user access

Here are a few important questions to ask as you determine the right fit – a balance of streamlined configuration and intentional user access – for your organization:

First, do you know your outsourcing strategy? Learn it. Read the contract, request the scope of work or a synopsis thereof:

• what is the CRO scoped to do?
• is it on a study by study basis OR 80/20 consistent activities OR other?
• is work done in CRO or Sponsor environment per the scope of work/contract?

Second, align the supporting documents:

• what does the CRO Oversight Plan say about system work?
• if there is no CRO Oversight Plan, make one.

Third, observe what is actually happening with your CRO partners:

• is the CRO performing in accordance with the scope of work as it relates to system activities?
• does this CRO user need the level of access that they have requested?
• if not, what steps are being taken to communicate, mitigate, correct, and document?

 

Now that we know how the CRO is contracted, we can address what the Sponsor system should support. It’s challenging for many small and mid-size Veeva customers to effectively tailor their Veeva Vault experience to the actual work being performed in the Vault environment. Keep in mind that Veeva Vault Clinical is intentionally designed to support a broad customer profile – biotechnology, medical device, and pharmaceutical companies in ALL phases of research and commercialization, across ALL indications. The out of the box offering is powerful, dynamic and comprehensive, but can also be overwhelming!

Reducing the “noise“ – Tailoring the Veeva Vault Clinical environment to your individual needs

Of particular importance for small to mid-size customers is to tailor the Vault environment – not by adding new configurations, but by strategically turning off features that, while beneficial, act more as noise and barrier to end-user adoption.

For example, if you utlilize a full-service CRO (one that performs most study activities), a Sponsor CTMS runs the risk of capturing duplicitous, out of date data, not to mention the resourcing burden for Sponsor with ingesting superfluous data.

The key question here is: what data elements do I need as the Sponsor to support (1) compliance and (2) the strategic portfolio?

Many out of the box fields in Vault CTMS are not required for an outsourced Sponsor and may create more “noise“ than potential business benefit. If the CRO provides a weekly report or output from their CTMS, it may be more beneficial to integrate or ingest their data rather than utilize scarce resources to perform duplicate data entry, particularly if these data points are not currently actionable or used.

Features to consider:

Expected Documents / Expected Document Lists

• Are we collecting the Expected Documents or is the CRO collecting, then updating the Sponsor eTMF (or sharing a weekly/monthly report)
• Can we eliminate or reduce the template EDL to better support our oversight activities, rather than duplicating work already done by the CRO?

Milestones

Workflows

• What document processes are actually taking place in our eTMF or CTMS?
• Do we need all of the possible out of the box workflows available to users or is it causing confusion?
• If we don’t need all available workflows, let’s turn them off so that users have only the relevant business processes available when actioning a document in the system.

The technology landscape puts capabilities at our fingertips, but just because we can do something doesn’t necessarily mean that it‘s the right thing, right this minute for our team(s). This simplified foundation provides a system environment primed for agile adaptation, rather than beginning from a place of overwhelm: start simple, then mature the system and supporting processes to meet your company‘s unique needs.

And, lastly, how to determine when to kick things up a knotch. Being intentional is of great importance, particularly in system management. We are the nexus point joining the limitless potential of modern technology with the business user experience. It is our role to facilitate clinical enablement, to make doing the work of bringing drugs, devices and biotechnology to market that much better – faster, safer, and more cohesive!

In our next post, we’ll speak to the unique needs of small to mid-size life sciences organizations as concerns strategic maturity and how that fits into a hybrid governance model, specifically designed to align with Veeva’s 3x annual release schedule. Stay tuned!

About the author

Kelly Butler joined fme US as a Consultant in the Consulting Services (Clinical) Team in October 2020 and her bio accounts for her strong Life Sciences expertise. After graduating from the University of Minnesota, Mrs. Butler began work as an Account Executive for UnitedHealthcare and returned to school to pursue her law degree with a focus on healthcare compliance and bioethics. Upon graduation, Mrs. Butler relocated to Raleigh, North Carolina and began her foray into clinical operations specific to R&D in the life sciences space. Recognizing the potential for greater efficiency across clinical operations in leveraging emerging technology, Mrs. Butler shifted her focus to the nexus of biomedical science, technology, and the human element: eClinical Systems. As a Consultant and Customer Success Manager with Veeva Systems, Kelly secured her Vault Platform White Belt Certification through Veeva’s credentialing process, as well as a Privacy Law & Data Protection Professional Certificate from Penn Medicine, University of Pennsylvania Health System.