Rethinking Study Startup with Novel Technology for Site-Sponsor Collaboration
Ashley Davidson, VP, Product Lead at Advarra, highlights how sponsors can unintentionally create more work for sites by not considering site workflows, what they’re doing to address site activation hurdles, and what sponsors can do to be more more supportive to sites.
Site burden has always been a trending topic in clinical research. What is the impact on study startup?
One major issue is that protocol design fails to consider site workflows. When trials are designed in isolation from those who will execute them, inefficiencies multiply. According to the Tufts Center for the Study of Drug Development, the average protocol has seen a 44% increase in total procedures over the past decade.
That complexity doesn’t just sit on paper—it lands on research coordinators and investigators who are navigating heavy workloads, disconnected systems, and growing expectations. Site burden isn’t a new conversation, but now it’s jeopardizing execution, timelines, and retention in ways we can no longer ignore.
How does the fragmented nature of technology impact site burden and study startup?
A 2022 SCRS Site Landscape Survey found that 76% of sites highlighted budgeting and technology pressures as top operational burdens, and many reported managing 20 or more trial systems per study. That’s a red flag. Sites are toggling between multiple platforms for regulatory, eConsent, EDC, scheduling, training, and more. Instead of streamlining work, these tools become the definition of burdensome. Sponsors should ask early, “What are we requiring of sites, and why? Are there procedures or data points that aren’t truly essential? Can tasks be consolidated or delegated?”
Our industry is at a breaking point. We finally have the technology to make things better, and the opportunity to solve this is real. So, the question is, "What are we waiting for?”
"When trials are designed in isolation from those who will execute them, inefficiencies multiply."
What technology does Advarra have to alleviate site burden during study startup?
At Advarra, we’ve seen that when sponsors are transparent about expectations and engage in better planning—especially when those critical due dates and milestones are visible to both the sponsor and the site—communication improves and frustration decreases. Our new site-facing study startup milestone tracker, Introduced in August 2025, within Advarra’s Study Collaboration solution supports this exact need.
How does the shared milestone tracker aid sites in the activation process?
The milestone tracker is designed to fit within—not interrupt—the flow of work for research sites during the activation process. Built with direct feedback from sites, it gives site staff a real-time view of what’s due, what’s upcoming, and what’s been completed across the study lifecycle. It's a simple concept with powerful impact. Every site is different, with unique SOPs and organizational workflows that are required for study startup.
While sponsor and CRO teams configure milestones and due dates, sites that use Study Collaboration are able to complete tasks in the order that work for them, as they know the most efficient path towards their activation. By aligning expectations clearly within the systems and processes that sites already use, we help eliminate confusion and manual tracking that often leads to unnecessary burden.
How does Advarra work to better understand site needs and turn that into meaningful innovation?
We’re in a unique position in that we’re not just building technology for sites—we’re in constant dialogue with them. Through our customer partnerships, long-standing relationships across the industry, and robust network of research sites that use Advarra technology every day, we have a direct line to site staff who tell us what’s working, what’s not, and what they need to do their jobs more effectively.
That feedback shapes our roadmap. When building our site-facing milestone tracker, site staff told us they were tired of working in silos—tracking timelines in spreadsheets, chasing down answers over email, and duplicating efforts across systems. What they wanted was a clearer, shared view of progress. Now, with site-facing milestones, sponsors, CROs, and sites can all work from the same set of expectations, in the same system, in real time.
The early response from key partners has been clear: less redundancy, less confusion, and more time spent on meaningful trial work. As one site leader told us, “This will give a lot of capacity back to our CRCs and research staff—and also keep the sponsor informed.” That’s the kind of alignment we’re working to scale across the ecosystem.
"We need to collectively move from a transactional to a partnership mindset. That includes investing in infrastructure that addresses the needs of all research stakeholders, modernizing contracts and payments, and treating sites as co-designers."
What are the core tenets of a site-supportive trial?
I’d highlight four:
First is simplicity. Strip down protocols to the scientifically necessary. Avoid gold-plating procedures that add operational burden without clear value.
Second is alignment. Ensure that trial operations reflect how sites actually work. This includes things like visit windows, source documentation expectations, and staffing assumptions.
Third is standardization. Sponsors and CROs can reduce unnecessary complexity by standardizing internal processes, data collection methods, and stakeholder expectations across studies. When each trial operates with different workflows, documentation, or system configurations, it forces sites to constantly relearn and adapt.
Fourth is to better understand your sites. Whether it’s streamlined training, consolidated communication, or clear escalation paths, trials should be built around respecting the site’s time and expertise.
How does the broader research ecosystem need to evolve to support sites better?
We need to collectively move from a transactional to a partnership mindset. That includes investing in infrastructure that addresses the needs of all research stakeholders, modernizing contracts and payments, and treating sites as co-designers—not vendors. It also means understanding that site capacity is finite. We cannot keep pushing more responsibilities without offering relief.
We also need to embrace technology that’s built with sites, not just for sponsors. If your study—like most—depends on sites to succeed, then supporting them is a strategic imperative, not a “nice-to-have.” The industry has been very focused on decentralization and digital transformation, which are important. But if we don’t also streamline how trials land at the site level, we’re not truly innovating—we’re just shifting the burden around.
