One company attempting to improve this process is Veeva, with the upcoming launch of its new study portal, designed to simplify research site access to sponsor technologies.
The cloud application, which will launch in December 2023, aims to “orient the needs of the sponsor and contract research organization (CRO) while streamlining processes for the site and the patient.”
In addition to study portal, Veeva recently unveiled VeevaID to provide single sign-on for clinical researchers across all sponsor systems, such as Veeva Vault EDC, Veeva Vault Study Training, and Veeva RTSM.
When sponsors use Veeva technology and enable VeevaID, the access links in study portal will take the user directly to the relevant study screen via single sign-on with no additional username and password required.
At Veeva’s R&D and Quality Summit 2023, Bio Pharma Reporter spoke with two of the individuals behind the new system – Jim Reilly, vice president of vault R&D, and Bree Burks, vice president of strategy, site solutions.
BPR: How are you helping research sites execute more effectively?
Jim Reilly: We've been focused on building site-centric technology that addresses the daily challenges investigators face. Most sites have a shoestring budget because they're funded by either government or sponsored research. They don’t usually have a budget for technology.
Veeva, as a Public Benefit Corporation (PBC), decided to help. Our approach is to look at what can streamline site execution, build great tech specifically for sites, and make it free. We've done that with Veeva SiteVault and continue to deliver new site-centric tools.
By offering free technology, we have more than 8,000 active site users and 1,500 sites that are active with Veeva SiteVault. Now, sites are embracing a consistent way of running trials and a consistent way to engage with their sponsors. It's starting to come through, and we're starting to make headway.
BPR: What will Veeva Study Portal and VeevaID help sites and sponsors do?
Jim Reilly: It's all about improving clinical research through technology. If sites can use consistent technology to execute trials and sponsors have a clear connection with the applications used by those sites, the industry will have a more consistent way of running research and drive greater efficiency.
Veeva Study Portal will allow sponsors and sites to organize the technology, usernames, and passwords used to execute trials all in one place, streamlining the site experience. With VeevaID, we're helping research site staff leverage one login to access Veeva applications and any other technology the sponsor asks the site to use. This will improve how sites and sponsors work together for faster adoption of tools and less administrative back and forth. Sites also benefit from this approach because they won't need redundant spreadsheets and sticky notes that are common during studies today.
Bree Burks: I'm a nurse by background and have worked within healthcare or academic medical centers, so I have first-hand experience with the plight of the site. To provide some context, can you imagine if you had to work across 15 different email systems that were all essentially similar? This adds complexity to everyday work. Site staff love patients, they like the science, but they don't want to have to focus on technology. Using multiple systems becomes a significant barrier that creates variation in their work. Variation is the enemy of quality.
Why do you think these challenges for research sites have persisted?
Bree Burks: The sponsor and site relationship right now is very transactional. I need this document, you missed a deadline, or you need to complete this training. With a complicated and transactional process, sites don't have time to focus on the things that can improve or accelerate a trial.
Questions like, where are you having a difficult time? What resources do you need? Do you need better training? What's not clear in these protocols? Sites and sponsors don’t have the time to talk about these things because the relationship is so tactical. We're already starting to make progress by giving sponsors and sites a space to come together and allowing them to focus on the things that matter.