With Michael Agard, Team Leader Clinical Consulting US at NNIT
Why are some pharma companies still using spreadsheets to manage clinical trials when Veeva’s Clinical Suite provides everything you need? The truth is that old habits and a lack of experience with Veeva are holding many organizations back. A root cause analysis of common issues is an efficient way to improve quality.
As a result of the increasing pressure to manage clinical trials faster and more effectively, pharma companies are looking to digital tools like Veeva Vault Clinical Suite to gain an advantage. 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 to stay competitive and drive down the time-to-market. Veeva Vault Clinical, combining clinical tools like the Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) in one platform, should be exactly what pharma companies are seeking.
However, in the experience of Michael Agard, Team Leader Clinical Consulting US at NNIT, modernizing the clinical systems is often a challenge for many organizations, in part due to the length of most clinical trials.
– If you want to upgrade your digital solutions during an ongoing clinical trial, you may have to run parallel systems until everything has been changed, and this can be a complex exercise. So, even though the benefits of switching to a platform like Veeva Vault Clinical are substantial, we still see organizations that run a significant part of their clinical trials using spreadsheets, says Michael Agard.
Companies neglect good data governance
One of the biggest mistakes that Michael Agard sees pharma companies make is underestimating the importance of good data governance and management. For example, some have over-customized the Trial Master File Reference Model, which provides best practices for standard content, structure, terminology, and metadata for the TMF. This increases both the risk of manual errors and the time spent on managing the trial data.
– Organizations that over-customize the Trial Master File typically need to 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. And often, it is simply old habits that prevent organizations from adopting the reference model.
This type of misstep during implementation can be fairly 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.
One of the challenges in working with a CRO is returning the TMF Documents and audit trail to the sponsor. The TMF needs to tell the story of the clinical trial and how Sponsor Oversight was managed. The migration of TMF documents, metadata, and audit trail data can be accomplished with a partner like NNIT, which has technical knowledge of Veeva Vault Clinical and knows the regulatory requirements for compliance.
“Even though the benefits of switching to a platform like Veeva Vault Clinical are substantial, we still see organizations that manage significant aspects of their clinical trials using spreadsheets.”
– Michael Agard, Team Leader Clinical Consulting US at NNIT
Find and fix issues with a root-cause analysis
In general, Veeva Vault Clinical 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? Michael Agard estimates that a company using Veeva Vault Clinical 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 fairly easy to adjust the input of metadata using required fields and auto-naming documents to reduce the likelihood of users 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 Michael Agard.
Valuable lessons about Veeva Vault Clinical Suite
As a leading Veeva partner, NNIT has participated in more than 450 completed Veeva 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 Suite has taught us that it is important to
- Save time on milestones and expected document management: In Veeva Vault eTMF and CTMS, you can manage milestones in clinical trials. Keep the milestone list simple and then associate a limited number of expected documents to 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.