It's Time To Change How We Engage Research Sites
By Maria P. Ladd, site operations consultant
"If not now, when?" This phrase, common in my family, captures two important truths: We shouldn’t delay progress, and we should seize the opportunities in front of us. In clinical research, that moment is now — and it carries powerful implications for all stakeholders.
It has long been acknowledged that the relationship between CROs, sponsors, and clinical research sites needs to evolve. This aligns with my experience, having been initially trained to work with sites in activation; it was basically an assembly line process. From feasibility and protocol design to engagement and inclusion, current systems of engaging research sites are often inefficient, one-sided, and/or outdated. Too often, we default to surface-level solutions — a new process, a shiny piece of tech — instead of real, systemic change. We need a shift grounded in communication and collaboration, not just profits and margins.
The Illusion Of Change
In years past, attempts at innovation have been discussed in venues large and small, only to have the initial intent fizzle out once monetization became the main objective. Take the COVID-19 pandemic. Yes, it prompted innovation. The rise of decentralized trials and remote tech solutions was a direct response to lockdowns. But that urgency didn’t translate into broad change in the way we interact with sites. It was a targeted solution to a specific problem, not a holistic rethinking of how we engage with sites at every level. Without a true philosophical shift within organizations, even the best ideas get trapped in silos or blocked by internal politics.
Real transformation requires addressing not just the tools we use, but the ego and inertia that stifle progress. It requires all stakeholders to dig deeply into the process and acknowledge what improvements can be made not only by their organization, but by them personally.
As it is not a one-sided problem, it is not a one-sided solution.
We’re In A New Era — If We Choose To Be
Metaphorical pendulums don’t stop at the center; they swing until a new balance is found. What strikes me now is a growing willingness to think differently. I’m experiencing more people open to new models, fresh approaches, and true collaboration. Clinical research, like most industries, is impacted by changes in government decisions, but never more so than in 2025 with the deep cuts in the FDA and NIH. The spark igniting a willingness to change may be due to a need to survive this period in our history, and hopefully will finally be the catalyst needed to move past “the way we’ve always done it.” While breaking away from that steadfast philosophical grip has been an historical challenge, we have an opportunity to allow a difficult time to provide positive outcomes.
This isn’t just about being innovative for innovation's sake. CROs, especially, need to evolve to keep up. With fewer trials, there is ever more competition among them — sponsors need their CRO partners to excel at the final goal — timely clean and complete data. From the CRO side, the untapped resource is harnessing the power of supporting sites throughout each stage of the process — site success equals CRO success. Their traditional revenue streams are thinning, and unless they climb to the top with new ideas, they risk being buried beneath their own weight.
This is the CRO’s time to shine by fostering the site/sponsor relationship and truly supporting sites to ensure their success in trials. Imagine a new norm where CROs guide sites through feasibility thoughtfully, creating processes to keep site data and not repeat all the same questions each time. I envision site support that begins at the beginning, learning what any given site needs for success — not defaulting to one-size-fits-all actions — and proactively stepping in with real-world guidance and assistance. These are just small examples in a world of possibilities; we don’t need high-tech to be higher touch for success. If hurdles are not allowed to become failures, everyone wins.
CROs and sponsors must take the lead, rethink how they treat and collaborate with sites, use the opportunity of the now to redefine strategies with an open mind. The result? Those companies which take the time and resources to change not only the face of these relationships but the heart of them will have faster timelines, quicker access to data and appreciable ROI for their efforts.
A Rise of Entrepreneurial Voices
CROs don’t need to go at it alone. 2024 and 2025 have sparked a wave of entrepreneurship in our field. Talented people are not letting the circumstances of the industry define them, and newly-launched businesses reflect that.
Particularly exciting are the organizations that highlight the research site. Those companies include iLumaSite, Curo Research, CSRS Research Naive Institute, Ridge Research Solutions, and ClinGRO. Notably, they are all led by women. But more importantly, in addition to offering site-oriented services, each works with sites at the granular level — mentoring, guiding, and teaching. As smaller, niche service providers, they can be utilized by the CRO or sponsor to step in and address specific site issues, helping struggling sites get back on track for a smaller financial impact than leveraging an additional site on a study.
One of the most critical benefits of engaging sites with thought and purpose by all stakeholders is the long-term need to have well-performing sites that make it past the first few studies. All too often, a less experienced site can become frustrated and just stop doing research.
Whether entrepreneurial efforts are broad in scope or more niche, newly founded organizations coming out of chaos are all part of a growing movement. Clinical research, as we know it, needs these motivated industry disruptors; we need to listen when they knock, because they come with fresh perspectives and the experience to build a strong future.
A Call To Action
The “when” is now. We should embrace this moment, you and I. We must champion the need for change and work together to support stronger site engagement and performance. Sitting in individual groups and stating the problems repeatedly to each other needs to expand to openly discussing ways to counteract the repeat problems. This should happen on platforms such as LinkedIn, with blog posts and articles, and in transparent discussions at conferences to spark tangible downstream improvements. Resulting solutions don’t need to be fancy. Here are a few simple, human-touch suggestions for strengthening the site relationship:
- Respect the sites’ time: Schedule calls and visits at their convenience and be prepared to lend a hand to whatever the challenges are. Treat them like your neighbor throughout the study and verbally express appreciation. This goes a long way when study hurdles present themselves — and they always will.
- Feasibility follow-up: When a site looks promising, but more information is needed, schedule a call. If a site doesn’t meet your criteria, send them an email right away with detailed feedback. There’s probably a site in the stack that has sent out a dozen questionnaires and heard nothing from any of them.
- Support for new sites and PIs: Give them trial opportunities, provide medical monitor or mentor time to ensure they understand what is needed, allow more robust monitoring time for staff and PI training. Pair a very experienced CRA with these sites.
- Start-up needs: Ask for what is necessary to meet regulations versus unnecessary requests, offer to complete documents, and begin ICF customization on their behalf. Emails with 30 bullet points noting what must be corrected is demoralizing.
- Enrollment begins early: Start early with support and maintain it. Don’t wait until everyone is frustrated and then ask why they can’t enroll. This should be (and remain) a proactive process while everyone is fresh and eager.
Sites, Are You Prepared?
Sites must be ready. This level of engagement requires preparation, training, and a site willingness to evolve in their processes, not simply hang on to how they’ve always done it. They must ensure resourcing and infrastructure within their organizations, showing a commitment to being the partner sponsors and CROs want to foster.
CROs and sponsors can and should provide more support and work with sites as partners — but the business of being prepared to conduct research is owned by the site. Have your SOPs and processes in top shape. Maintain adequate staff as you accept studies and ensure thorough training is provided. Learn from the CROs and sponsors and outsource these foundational actions, if needed. Ask the CRO and sponsor for mentorship if clinical research is still a learning curve. Voice what you need to succeed. My experience is that the majority of CROs and sponsors are willing to provide what is needed, even if it isn’t immediately evident from the site perspective, because in the end, the site is where the sponsor’s goals are realized.
About The Author:
Maria Ladd has been in the clinical research industry for nearly 20 years. She is a passionate site advocate, a site operations consultant and founder of iLumaSite, and co-founder of the Clinical Research Site Collective. As a key collaborator and champion of change for site engagement, Maria can be found on LinkedIn where she lends a strong voice to the clinical research community at large.