Building strong partnerships with sites and investigators for more effective clinical trials

When I first entered the clinical research industry more than 20 years ago, trials were focused mainly on recruitment goals and data collection, with less attention to the challenges faced by research sites.

While working at a site, I saw firsthand the administrative and operational hurdles of study start-up, patient recruitment and trial execution. Today, the industry has evolved and site engagement is now a crucial factor in successful clinical trials.

Clinical trials are becoming more complex, often requiring sites to manage multiple technologies, each with its own login.

This adds administrative burden and makes it difficult for site staff and investigators to integrate these tools into their busy workloads.

As patients and staff report preference for hybrid trial models, sites face increased pressure to find and engage patients, meet tight deadlines and stay within budget, all while ensuring high-quality data.

Close collaboration between sponsors, CROs and research sites is key to overcoming these challenges.

I’ve learned that a patient-centric approach only works when we’re also site-centric, as the relationship between sites and patients is essential for clinical research success.

Sites need patients to enrol, and patients join trials to support research and bring new treatments to market. Without participation and proper support for both sites and patients, even well-designed trials can struggle.

Early and ongoing site engagement is now essential, ensuring sites can focus on delivering quality data, managing patients and meeting deadlines.

As CROs, it’s our responsibility to engage sites early and help them navigate their increasingly complex work.

This is where our three-step approach to site engagement comes into play:

Step 1: Early Engagement and Feasibility
Engaging with sites early in the trial planning process is crucial. Prior to focusing on a site’s capabilities, patient populations and past performance, we seek its feedback in design, opportunity to ease operational complexity, and further outline what it needs to succeed. We then ask key questions: Does this site have experience, skill set and staff within the therapeutic area under study? Can it realistically recruit the target number of patients? By establishing this feasibility early, we help ensure that the site is established for success.

We also create a library of pre-prepared documents – budgets, contracts, feasibility assessments – so that once the trial has started, we can move quickly to activation.

Step 2: Ongoing support and communication
Once the trial is underway, maintaining clear and consistent communication with sites is key. Sites need to feel supported – not just during the initial stages but throughout the trial.

Our team makes sure they have access to the right tools and resources, and we actively seek their input. Whether it’s protocol feedback or real-world insights from investigators, we recognise the value of the site’s perspective in shaping a successful study.

Continuous dialogue helps reduce site burden and ensures that all parties – site, CRO, sponsor – are aligned on expectations, timelines and deliverables.

Step 3: Long-term partnership and feedback
The final step is building long-term partnerships with sites that go beyond a single study. Sites want to be valued for their expertise, not just patient recruitment.

These lasting relationships help streamline future studies, build trust and reduce administrative tasks. It’s also crucial to provide sites with a platform to share feedback, so we can continuously improve our support to them.

In my experience, managing successful clinical trials relies on building strong partnerships with sites through ongoing support and collaboration.

Sites are key to recruiting, retaining and engaging patients, which directly impacts data quality and the development of new therapies.

By fostering these relationships, we empower sites to succeed, ultimately benefiting patients with new, life-improving treatments.

Tracy Donahue is Director, Global Feasibility & Site Engagement at Advanced Clinical.
Go to advancedclinical.com