Vault CTMS: Moving Closer to Patient-Focused Trial Management

In 2017, Veeva launched Vault CTMS to provide a single source of truth for life sciences companies managing end-to-end clinical trials. Traditional Clinical Trial Management Systems (CTMS) struggled to improve operational efficiency and required long expensive software implementation cycles. We wanted to build something flexible for, and with, the life sciences industry.

Achieving the potential of CTMS: work in progress

Improving the software used for clinical operations has a human impact. Technology can facilitate effective collaboration and widen patient access to the latest clinical studies. By enhancing overall study efficiency and accuracy, new therapies can be delivered faster to the patients who need them. It’s why I love coming to work every day.

CTMS technology has progressed since its introduction in the 1980s, but it has a long way to go before achieving its full potential. When I first started working on CTMS implementations in 1998, the software had already been around for 10 years, yet the vendor ecosystem was nascent. CTMS had huge potential to streamline workflows between sponsors, sites, and Contract Research Organizations (CROs), but progress stalled.

By 2016, I’d worked on more than 100 CTMS implementations, and noticed some depressing patterns: implementation costs of up to $500 million, five-year timelines, the difficulty of finding a compelling ROI. In addition, complex integration projects were required to connect multiple data sources to CTMS, robbing resources needed for other strategic endeavors and undermining overall business performance.

Clinical operations teams paid a steep price. We’ll never know how many Clinical Research Associates (CRAs) burned out after having to navigate between 10 and 20 systems just to complete a single task. Operational inefficiency didn’t discriminate, slowing down sponsors and CROs alike.

Expensive configurations and upgrades had a serious impact on clinical research, delaying results, causing teams to miss milestones, and putting important research at risk. Centralized data and a single source of truth were needed to make quick, well-informed decisions.

I couldn’t remember the last time I had seen a customer smile or say thank you. The sheer effort required to use existing CTMS technology drowned out the reasons why the technology had been adopted in the first place.

Flexible technology built for, and with, the industry

In 2017, Veeva launched Vault CTMS to address the widening chasm between expectations and delivery in clinical trial management software. Our goal was to deliver on the industry’s initial hopes for CTMS: faster, better-executed trials that facilitate patient entry into studies.

If we were to reach that target, we needed to collaborate closely with the industry, and our solution had to be as flexible and inclusive as possible.

Our core team members brought diverse perspectives to the project, but we had all experienced the pain points that needed to be removed from CTMS. None of us wanted to replicate what was already out there, so we started with a blank canvas, knowing the system would sit within the overall architecture of the Veeva Vault platform.

Most importantly, we asked the industry to partner with us, closely collaborating with some of the top 30 pharma companies. This work enabled significant improvements and evolved CTMS in a better direction. Prototypes were rigorously tested, and feedback from pharma directly shaped software development. As a result, Vault CTMS went through nearly 25 iterations before it was launched. Equally telling, more than half of our industry collaborators became early adopters of the application.

Making Vault CTMS the easiest solution to use was a key goal but it was far from our only objective. The technology had to be flexible enough to meet the full spectrum of stakeholder needs, ranging from CROs to small biotechs, large pharma companies to MedTech, across Europe, North America, and Asia. How well we succeeded would determine the adoption rate.

We were determined to eliminate the complex workarounds that drained time and resources, preventing the industry from meeting its strategic goals. Previous versions of CTMS required companies to support multiple versions of the software. By focusing our expertise on innovation, across strategy, product, and engineering, we have helped free our customers’ teams from time-consuming manual tasks so that they can focus on improving patient outcomes.

Single source of truth for clinical operations

Five years after our launch, I’m proud to say that Vault CTMS continues to bring sponsors and CROs closer to the patient-focused, science-driven vision of clinical trials. Freeing users from integration and customization allows them to prioritize end-to-end trial efficiency and quality.

This new approach to CTMS is clearly reflected in the way site monitoring is handled today. With previous technology, site monitors were forced to wait hours before they could access trip reports because custom integrations were needed to connect applications on different platforms. Today, taking a unified approach to data, workflows, and processes means that monitors and study teams can move easily between visit reports in Vault CTMS and associated casebooks in Vault EDC. One top 20 pharma company has seen a 50% reduction in the time required to author monitoring visit reports, an improvement that will save 100,000 person-hours per year. At the same time, the number of software integrations has dropped from 45 to 24.

CROs and sponsors alike need to improve clinical trial speed and agility. Reducing reliance on manual processes, and improving oversight, are crucial.¹ When trial data and processes were managed in legacy software, and patient-informed consent was collected and stored on paper, sponsors and CROs couldn’t share information efficiently. Automating with Vault CTMS has eliminated manual processes and made data more accessible, reducing the time spent on data entry and streamlining document filing.

Having one single source of truth has enhanced study oversight and benefits both sponsors and CROs. One biotech sponsor notes that this new approach, and having Vault CTMS unified with Vault eTMF, has saved the organization 30 minutes per monitoring event. Greater transparency and visibility to trial progress enable companies to change course if they need to and make it easier for CRAs to track protocol deviations, which have become increasingly common as trials become more complex and dynamic.

Higher-quality trials, better patient outcomes

In the five years since we introduced Vault CTMS, Veeva’s guiding principle has never changed. We believe that technology should facilitate information flow to improve clinical processes and overall efficiency and quality. We understand, both as a team and as a collaborator with pharma companies, CROs, biotechs, and MedTech, why this is so crucial to the industry and patients all over the world. More effective collaboration will make it easier to enroll patients and speed up access to life-changing treatments.

Our unified approach allows clinical teams to run trials at the speed they need and focus on innovation and patient needs. In the end, that’s the legacy that we are all striving for.

Hear what our customers are saying about Veeva Vault CTMS.