4 Steps to Improve Clinical Research Site Collaboration

Karen Whitson, associate director, study operations, AbbVie

In the past five years, there’s been an explosion of new technology made with the intention of addressing patient needs. But, these good intentions have yielded mixed results. For example, sponsors may ask patients to wear a new watch, carry a new phone, or remember several different logins. Sites are feeling the impact too – juggling trials with multiple sponsors, different protocols, and hundreds of devices.

Our team at AbbVie has been laser-focused on finding ways to improve our collaboration with sites, automate document exchange, and streamline our study startup process. We started by implementing Vault eTMF in 2014, then Vault Study Startup in 2021. In July 2023, we launched a program-specific campaign utilizing Vault Site Connect with eight studies and 1,600 sites. Since then, we’ve seen:

• 100% of studies in our initial rollout now use Site Connect
• 410% increase in connected studies
• 78,488 safety letters distributed through Site Connect via email

Here are four steps our team took that could help your organization create a scalable blueprint for seamless site collaboration.

Step 1: Reach out to your industry peers

Before rolling out new software, tap into your network of colleagues at other sponsors to collaborate, share experiences, and learn from each other. For example, our team at AbbVie got the idea to centralize our interactions with sites at a Veeva Site Connect community meeting in April 2023. This meeting laid the foundation for our Site Connect rollout and helped us work toward providing sites and monitors with a direct line of communication as we implemented Site Connect. Remember: plenty of sponsors have gone through organizational transformation. You don’t have to go it alone.

Step 2: Open direct lines of communication

Sites are inundated with new technology in every study they take on. Anything you can do to ease that burden will be greatly appreciated by monitors and site staff. This includes keeping all communication concise and strategic. One of our priorities at AbbVie was simplifying our outreach memo to provide clear action items for principal investigators (PI), site coordinators, and study monitors. Ultimately, we pared down the memo to only three steps:

• Register with Veeva
• Receive your universal site number (USN)
• Send your USN to the AbbVie team so we can connect it to our system

We utilized a question-and-answer tool that provides internal personnel a means to direct their questions to the appropriate team. The questions are categorized by system and process, so people’s questions get routed to the correct subject matter experts (SMEs) for a timely response.

Step 3: Centralize information

To smooth the transition to Site Connect, create a centralized location for all of your system processes and documents. Our team at AbbVie created a focused list of Veeva resources for our site monitors. We also kept track of the questions coming through our internal question-and-answer system to create an FAQ document for easy reference.

Step 4: Focus on relationship building and reinforcement

Building strong relationships with site staff and monitors is critical to increasing software adoption. Often, site monitors are wary of new technology because they may feel obligated to train site staff on top of their existing responsibilities. We emphasized to our site monitors that they were not accountable for training their sites on Site Connect. Instead, we encouraged them to lean on the Veeva Site Success team as Site Connect continued to gain traction.

As your initial rollout grows, be sure to share metrics and successes with sites. At AbbVie, we noticed that as site monitors saw Site Connect use ramping up at their sites, they became more enthusiastic about encouraging adoption. Although they were hesitant due to the constant change, seeing these successes first-hand helped monitors get on board.

Next steps for AbbVie

Now that we’ve successfully launched our initial rollout, our team at AbbVie is looking forward to expanding Site Connect use to all of our studies. We’ve created a strong blueprint that we will scale globally to streamline site collaboration, simplify information sharing, and reduce site burden.

Learn more about how Vault Site Connect can streamline your trial.