Veeva announced that its clinical trial management system (CTMS) Vault has been implemented at Bristol Myers Squibb (BMS). According to the cloud software provider, the implementation of CTMS made it possible to combine two legacy systems into one in a relatively short time.
To learn more about how installing Vault can help companies like BMS streamline their operations, Outsourcing-Pharma spoke with Jim Reilly, Vice President of Vault R&D and Quality for Veeva. He shared his perspective on the challenges he’s encountered in the industry when managing legacy systems, how a modern CTMS can streamline processes, and what his company is doing to help advance the execution of clinical tests.
OSP: Could you please share some of the challenges of conducting clinical trials with traditional legacy technology?
JR: We have seen a shift in the industry from using point solutions to address specific use cases to adopting a complete, connected solution for all clinical trial activities. Traditionally, industry has used bespoke applications to manage trial execution, scheduling and site engagement. But this forces end users to switch between apps to initiate a study and is incredibly inefficient.
To solve this problem, some companies use tracking sheets around the software landscape to tie processes together. This creates a “Wild West” of point solutions with a tracking tool as glue. Disjointed infrastructure increases risk, makes cross-functional collaboration more difficult, and requires manual processes that can slow down testing.
OSP: How is Veeva’s Vault CTMS poised to help break down some of these barriers?
JR: Vault CTMS is part of the Veeva Vault clinical suite, so customers benefit from powerful trial management and monitoring capabilities in the same environment, as well as trial master file (TMF), startup study and payment on site. This allows companies to conduct a study end-to-end on a single platform while providing end users with a single location to perform clinical processes, regardless of their role in the trial.
Many traditional CTMS are 20-25 years old and have changed very little from a capability perspective, making it more difficult to complete trial processes in a dynamic study environment. Using a modern cloud CTMS ensures that businesses can continually evolve their processes and take advantage of seamless technology upgrades that can add new capabilities and features as market demands evolve.
Closed-loop issue management is a great example of how we help customers keep up with industry changes. Rather than simply identifying issues or deviations taken during a test, Vault CTMS applies a process to close the loop and mitigate or resolve issues. This avoids trial delays and keeps studies on track. Vault CTMS also helps move trials forward by offering risk-based study management directly in the system instead of requiring companies to implement a separate solution.
Vault CTMS also helps companies improve operational efficiency on a global scale. There are specialized requirements for registering a trial in Japan, and companies had to add a local software application to help with trial notification. Veeva has now integrated this process into the CTMS to make it easier for customers.
OSP: You mention in the announcement that the implementation time was relatively quick for the BMS. Why is it beneficial to have a rapid implementation of CTMS?
JR: CTMS is sometimes described as the heart – or cornerstone – within the clinical trial technology ecosystem, as it connects to all other solutions across clinical trials. Implementing a new CTMS can be a big effort because you have to worry about all the connective tissue around it.
Adopting Vault CTMS removes the need for countless integrations due to its pre-built connections to Vault CDMS, Vault eTMF, etc. The platform’s design, with open APIs, facilitates integration with third-party systems. Thanks to this and Veeva’s agile framework for software implementation, we can implement CTMS faster than previously possible in the industry.
OSP: Anything to add?
As an industry, we are all trying to move to a more digital way of working, which means eliminating paper-based processes. Sometimes I talk about it like paper on glass, and an example of that is the site monitoring visit reports that are usually filled out in a CTMS.
Surveillance visit reports have always been on paper, where an ARC documents findings and follow-up actions based on a site visit. In Vault CTMS, we’ve made it a digital process to eliminate the use of paper. Companies using Vault CTMS with other Veeva clinical applications can now streamline site monitoring and share data seamlessly with key stakeholders. This ensures that everyone can access real-time data and reduces the risk of non-compliance, helping to make testing faster and more cost-effective overall.