As a global leader in medical devices, this company handles some of the most complex trials to date. Yet, they relied on a multi-vendor mix of siloed point solutions that resulted in delays and manual workarounds. The company’s head of clinical operations knew they needed to make a change.
“It became our mission to replace manual systems and processes with newer, more modern ways of working,” explains the head of clinical operations. “We wanted to spend our time on what matters most: making great products to enhance the quality of life for our patients today. That meant waving goodbye to manual spreadsheets and long email chains. We wanted an automated flow of information between connected systems.”
Working closely with Veeva Systems, the company moved toward a unified platform approach. “We went live with the Veeva Vault Clinical Suite very quickly and hit our milestones well before our target timelines. Our goal was to go live with six studies in the first few months and we hit over thirty,” says the head of clinical operations. “I highly recommend consolidating information and systems when you can,” adds the company’s associate director of clinical trial document management. “Before, we had to search across multiple systems to find what we needed. Now, we have everything we need to create and manage a study all in one place.”
Accelerating the clinical trial process
Vault Clinical Suite has increased the efficiency and agility of the company’s clinical operations and data management. According to the global head of clinical R&D, “Veeva Vault is all about speed and simplicity.” By providing a single source of truth, Veeva delivers end-to-end process visibility, increases internal and external collaboration, and decreases time to market. The company considers the implementation of Veeva’s clinical systems a “raving success,” with nearly 100 studies managed in Vault CTMS after only six months of use.
One highlight of their journey is the transformation of the trial data manager’s role. Vault CDMS reduced the technical expertise required to build studies by eliminating the need for custom programming. Data managers are now empowered to support trial teams by designing and building studies themselves. The company’s more technical data managers were able to learn the basic rule programming in Vault EDC, and the expanded role has improved their job satisfaction and resulted in faster study builds with no extra headcount. The move has also freed the company’s database developers to focus on building standards and any complex programming tasks.
Streamlining site payments
Before implementing Vault EDC and Vault Payments, the company manually tracked all site payments. “I had to put every patient at every site into a spreadsheet and figure out which visits they completed to send the due payments. For a 20-site study with 400 patients in it, it took me days to log the information,” remembers the head of surgical trial management operations. “Now that we’ve gone digital and automated payments, we’ve seen huge time savings. When the data is entered, we’re immediately ready to start processing the payment downstream.”
Smooth implementation and quick go-live helped the company avoid any lag-time between system changes. “The integrations in prior systems were so complex that it took two to three years to complete. While we waited, we were still stuck doing it all manually,” says the head of surgical trial management operations. “With Veeva, Vault Payments went live the same day as the rest of the Vault Clinical Suite. We were never forced to create any elaborate, custom reports as a go-between while we integrated.”
Information from subject visits automatically transfer from Vault EDC to Vault CTMS to help populate monitoring trip reports and automate site payments. Now, nearly all of the company’s payments are fully automated. If a signature is needed, all the relevant information is displayed on one page for all different studies. And, the team has been able to scale the solution quickly and easily since implementation. Currently, they’re using Vault Payments on 100+ studies and nearly 300 sites, with an average monthly paid amount of over $600,000, and a total value of payable items exceeding $26,000,000.
Leveraging a connected platform
In addition to the Vault Clinical Suite, the company implemented Veeva MedTech across its quality, regulatory, and commercial organizations. Deploying a connected platform across the enterprise has allowed them to streamline cross-functional business processes and improve data quality. “We have a single source of truth for all our documents,” explains the clinical trial document manager. “The Investigator’s Brochures and Clinical Study Reports are created and managed in Vault RIM and are readily available in our TMF. It makes things so much easier.”
Moving forward, the company will pursue more opportunities for business transformation with new connections between Veeva applications and other systems. “We have already accomplished a tremendous amount and achieved so many milestones,” says the vice president and head of clinical operations. “Going digital with Veeva is a true partnership. It is transforming how we work in clinical and presents an enormous opportunity for the broader company.”