Veeva has introduced that its Vault clinical trial management system (CTMS) was put in place at Bristol Myers Squibb (BMS). According to the cloud software provider, the implementation of the CTMS helped bring together two heritage systems into one in a relatively short time.
To learn more about how Vault installation can help companies like BMS help streamline operations, Outsourcing-Pharma spoke with Jim Reilly, vice president of Vault R&D and quality for Veeva. He shared his perspective of challenges he’s seen across the industry when managing legacy systems, how a modern CTMS can streamline processes, and what his company is doing to help advance clinical trial execution.
OSP: Could you please share some of the challenges of running clinical trials with traditional legacy technology?
JR: We've seen an evolution in the industry, moving from using point solutions to address specific use cases to adopting a complete and connected solution for the full breadth of clinical trial activities. Traditionally, the industry has used bespoke applications to manage trial execution, planning, and site engagement. But this requires end-users to jump from application to application to get a study going and is incredibly inefficient.
To address this issue, 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 the glue. A disjointed infrastructure increases risks, makes it harder to collaborate cross-functionally, and requires manual processes that can slow down trials.
OSP: How is Veeva's Vault CTMS poised to help clear away some of those obstacles?
JR: Vault CTMS is part of the Veeva Vault Clinical Suite, so customers gain powerful trial management and monitoring capabilities in the same environment along with the trial master file (TMF), study start-up, and site payment solutions. This allows companies to run a study end-to-end on a single platform while providing end-users with one place to execute clinical processes, regardless of their role in the trial.
Many traditional CTMS are 20 to 25 years old and have changed very little from a capabilities perspective, making it harder to complete trial processes in a dynamic study environment. Using a modern cloud CTMS ensures that companies can continuously evolve their processes and leverage seamless technology upgrades that can add new capabilities and features as market demands change.
Closed-loop issue management is a great example of how we’re helping customers keep up with industry changes. Rather than just identifying issues or deviations taken during a trial, Vault CTMS enforces a process to close the loop and mitigate or resolve issues. This prevents trial delays and keeps studies on track. Another way Vault CTMS helps advance trials is by offering risk-based study management directly within the system instead of requiring companies to bring on a separate solution.
Vault CTMS is also helping companies improve operational efficiency globally. There are specialized requirements for registering a trial in Japan, and companies have had to add a local software application to assist with trial notification. Veeva has now built this process into the CTMS to make it easy for customers.
OSP: You mention in the announcement that the implementation time was relatively swift for BMS—why is it beneficial to have a rapid CTMS implementation?
JR: The CTMS is sometimes described as the heart - or the lifeblood - within the clinical trial technology ecosystem since it connects with every other solution across clinical trials. Implementing a new CTMS can be a significant endeavor because you must worry about all the connective tissue around it.
Adopting Vault CTMS removes the need for countless integrations because of its pre-built connections to Vault CDMS, Vault eTMF, etc. The way the platform is designed, with open APIs, makes integrating with third-party systems easier. Because of that and Veeva's agile framework for implementing software, we can implement CTMS faster than was previously possible in the industry.
OSP: Anything to add?
As an industry, we're all trying to move to a more digital way of working, which means removing paper-based processes. Sometimes I talk about it as paper on glass, and an example of that is site monitoring visit reports which are usually completed in a CTMS.
Monitoring visit reports have historically been paper-based, where a CRA documents findings and follow-up actions based on a site visit. In Vault CTMS, we made this a digital process to eliminate the use of paper. The companies using Vault CTMS with other Veeva clinical applications can now streamline site monitoring and seamlessly share the data with key stakeholders. This ensures everyone can access real-time data and reduces the risk of non-compliance, helping to make trials faster and more cost-efficient overall.
