With Jennifer Thomas, Advanced Business Consultant, at NNIT
Why are some pharma companies still using spreadsheets to manage clinical trials when Veeva Vault Clinical Operations Suite provides everything they need? The truth is that old habits are holding many organizations back.
In an effort to manage their clinical trials faster and more effectively, many pharma companies are looking to Veeva Vault Clinical Operations Suite. The drive to optimize is especially relevant for the increasing number of companies electing to outsource their clinical studies to a Clinical Research Organization (CRO), where communication between sponsor and CRO adds an extra layer of complexity.
Reducing the burden of data and document management, while also streamlining communication between CRO and the clinical trial sponsor is essential. By combining clinical tools like the Vault CTMS and Vault eTMF in one platform Veeva Vault Clinical Operations Suite is exactly what pharma companies need to stay competitive and drive down the time-to-market.
In the experience of Jennifer Thomas, Advanced Business Consultant at NNIT, many organizations find it challenging to modernize their clinical systems, in part due to the length of most clinical trials. But the benefits are worth the effort.
– Even though the benefits of switching to Veeva Vault Clinical Operations Suite are substantial, we still see organizations that run a significant part of their clinical trials using spreadsheets. This is because it can be a complex exercise to upgrade your digital solutions during an ongoing clinical trial. Until everything has been changed, you may have to run parallel systems, says Jennifer Thomas.
Companies neglect good data governance
Often, it is simply old habits that prevent organizations from gaining the maximum benefit from Veeva Vault Clinical Operations Suite. One of the biggest mistakes that Jennifer Thomas sees pharma companies make is underestimating the importance of good data governance and management.
For example, some companies tend to over-customize the Trial Master File Reference Model, which provides best practices for standard content, structure, terminology, and metadata for the TMF.
Organizations that over-customize the Trial Master File typically experience more manual errors and spend more time managing their documents, especially for the exchange of documents with CROs. This is a good example of the importance of making the right choices early during implementation of a new system because otherwise, it can have long-term consequences.
This type of misstep during implementation can be easily avoided by relying on an implementation method that uses industry best practices. NNIT has achieved reliable results using such an approach when working with clients, especially with organizations with limited internal resources. NNIT can also assist with the migration of TMF documents, metadata, and audit trail data between CRO and sponsor.
“Even though the benefits of switching to Veeva Vault Clinical Operation Suite are substantial, we still see organizations that manage significant aspects of their clinical trials using spreadsheets.” – Jennifer Thomas, Advanced Business Consultant at NNIT
Improve performance with a simple analysis
In general, Veeva Vault Clinical Operations Suite users can often improve their performance and results significantly with a root-cause analysis of their quality issues. Is a particular type of document, classification, process, or study-specific nuances causing most of the problems?
Jennifer Thomas estimates that a company using Veeva Vault Clinical Operations Suite can identify and address most of its top ten issues with a simple analysis.
– In one case, a company required a lot of its data to be entered via a free-text field, which resulted in frequent manual errors. It was easy to adjust the input of metadata using required fields and auto-naming documents to reduce users' likelihood of entering incorrect information. Sometimes, users need to be re-trained, or processes need to be reviewed more thoroughly. It is all a matter of examining the data closely, says Jennifer Thomas.
Valuable lessons about Veeva Vault Clinical Operations Suite
As a leading Veeva partner, NNIT has participated in more than 450 completed Veeva Vault projects. We know that aligning the whole organization with a new paradigm of continuous improvement is essential for success.
Our vast experience with Veeva Vault Clinical Operations Suite has taught us that it is important to
- Save time on milestones and expected document management: In Vault eTMF and Vault CTMS, you can manage milestones in clinical trials. Keep the milestone list simple and then associate a limited number of expected documents with a milestone. This replaces the use of placeholder documents and enables much more efficient TMF completeness oversight.
- Don’t go overboard on user permissions: Some organizations tend to over-configure user permissions, which ends up hindering team members from doing their work. To resolve this, you often need to differentiate between company roles and user permissions.
- Plan carefully for decentralized trials: There is an increased interest in decentralized trials, where patients can participate through their local pharmacy instead of at a central site. While this method has multiple benefits, you are adding a lot of people to the team, who may not have a lot of experience with clinical trials. You need to adjust your technology platform, processes, oversight, and training accordingly.
