Alliance Clinical Research is a dedicated research center committed to improving the quality of health in their community through innovative clinical trials. Alliance’s director, Luis Ruda, is passionate about his organization’s motto: We’re serious about clinical research. Ruda believes that clinical research is unlike any other business. “We’re trying to help patients find solutions to their conditions.”
Alliance specializes in a variety of therapeutic areas including cardiology, dermatology, gastroenterology, hematology, and nephrology. With this diversity comes complexity and administrative burden. Managing study documents in paper binders was an ongoing challenge—and the challenge was growing bigger with each new study.
The Problem
Ruda believes that for clinical research to be truly innovative, sites must have a strong technology foundation. He was frustrated with the limitations and inefficiency of paper binders. The real estate and material expense was difficult to justify given the long-term administrative effort required to keep each binder up-to-date and compliant.
When Ruda received questions from his study partners, he struggled to respond promptly. “I didn’t have access to the information I needed right away. I’d have to pull out a binder and flip through hundreds of pages to find a single document. It took a lot of time.”
Ruda saw how electronic health records transformed clinical operations at trial sites. “So many other aspects of my business are enhanced with technology. I knew the same innovation was possible for our study binders.”
The Solution
To improve efficiency, access to information, and reduce operating costs, Ruda turned to eRegulatory software. He needed a solution that was easy to implement and use to reduce the administrative workload on his study team.
“My coordinators were able to access the software quickly and use it to reduce their workload within days.” – Luis Ruda, Director, Alliance Clinical Research
After reviewing several vendors, Ruda discovered that many systems weren’t affordable and could take months to implement and learn.
After hearing that Veeva offered a free eRegulatory system for sites, Ruda was immediately interested. “I knew that Veeva was a well-known company and that many of my sponsors used Veeva software.” Upon learning more, Ruda discovered that Veeva SiteVault Free met his requirements for ease of use. So he signed up.
“The implementation was very, very smooth. The system is self-explanatory, and training was simple. My coordinators were able to access the software quickly and use it to reduce their workload within days.”
Feedback from Alliance’s study partners was also positive. Since many of their sponsors use Veeva products, minimal training is needed and they can login using the same credentials across all systems. “It just makes communication and working together a lot easier for both companies,” said Ruda.
When they had questions, Alliance turned to Veeva’s support team. “They were receptive to our questions and had the answers right away. They even shared their screen so we could follow along. It was so easy,” said Luis.
The Results
Within eight weeks, Alliance is managing all of their studies within SiteVault Free. When reflecting on the reasons for transferring both new and ongoing studies into the system, Ruda cited the need for immediate results. “The time we spend now saves us a considerable amount of time in the long run.”
The entire team at Alliance finds SiteVault Free saves them time and reduces administrative burden. Ruda’s PIs can access information and sign documents from any online device. Coordinators can quickly send signature requests and make sure their binders are up to date. “We can see all expiring documents in one report. It’s just so much easier,” says Ruda.
“The time we spend now saves us a considerable amount of time in the long run.” – Luis Ruda, Director, Alliance Clinical Research
Ruda’s team can continue to work with monitors and sponsors without the need for frequent onsite visits. Sponsors and monitors also appreciate the increased efficiency and transparency that SiteVault Free provides. Once granted access, monitors assigned to Alliance’s studies can remotely access study documents when needed.
When Ruda receives an urgent question, he can respond right away. “When a sponsor sees that the site is responsive and engaged in a study’s dialogue, they feel confident in the site’s work. SiteVault Free strengthens our relationship with sponsors.”
“Veeva SiteVault Free helps us dedicate more time for patient recruitment and care.” – Luis Ruda, Director, Alliance Clinical Research
More Time for What Matters Most
With the time savings realized, Alliance can prioritize their most business-critical goals. Ruda’s team can focus on patients, study conduct, and recruitment. “The more time available for recruitment, the more likely we will be successful with the studies that we were assigned. Veeva SiteVault Free helps us dedicate more time for patient recruitment and care,” said Ruda.
As for other research sites who are looking for an eRegulatory solution, Ruda has some advice: “Don’t be afraid of change. SiteVault Free is so easy to set-up and use – consider it an investment in the long-term happiness of your team and the success of your business.”
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