Choosing the right clinical trial site is a critical decision for pharmaceutical companies, but it’s only the beginning. Once the trial begins, how do you know your site is truly performing?
Sponsor confidence in trial performance can’t be based on gut feeling or good communication alone. You need measurable indicators that reflect how well a site is executing the work that keeps your trial on schedule, your data clean, and your regulatory path clear.
In a recent cardiovascular disease trial, a sponsor assessed the performance of RDI across four key domains: enrollment, protocol deviations, query resolution, and data entry timeliness. Each of these areas has a specific set of metrics that matter for tracking performance and predicting outcomes.
Here’s a closer look at what to measure, why it matters, and how RDI’s real-world clinical trial site performance brought these metrics to life.
Enrollment: The First Way Research Sites Can Fall Behind or Pull Ahead
Sponsors know that enrollment delays are one of the most common and costly barriers to keeping a trial on track. But the problem isn’t just slow participant recruitment; it’s the time lost scrambling for backup sites, requesting amendments, or justifying timelines to leadership.
The earliest indication of whether a site can deliver is how well it meets enrollment targets — not just once, but if and when expectations shift. That means sponsors should look at:
- Actual Vs. Baseline Enrollment to see if the site performed as initially promised.
- Actual Vs. Latest Forecast to see if the site could adapt to mid-study changes.
A clinical trial site that performs well here is proactively managing outreach, screening efficiently, and staying aligned with the sponsor every step of the way.
RDI’s study assessment results: In the cardiovascular trial, RDI has hit 100% of their original and latest enrollment target goals, enrolling a total of 20 participants at their site.
Protocol Deviations: A Telling Sign in Any Site Performance Evaluation
No sponsor wants to see deviations in a monitoring report. But it’s not the existence of deviations that’s most concerning; it’s the type and frequency.
Important deviations — the kind that affect patient safety, data integrity, or endpoint evaluability — speak volumes about a site’s internal control, staff training, and a culture of quality. They’re ultimately friction points that can trigger expensive CAPAs, delay study milestones, and raise red flags with regulators.
That’s why the % of important deviations is one of the clearest indicators of how tightly a site runs its operations.
RDI’s study assessment results: When the sponsor conducted their mid-study assessment, they found a total of 16 deviations. Of those 16, zero were deemed important deviations.
Query Management: A Daily Practice That Shapes the Clinical Research Timeline
If deviations tell the story of how well a clinical trial site follows the plan, queries tell you how well they engage with the trial data.
Every unanswered or reissued query slows things down. Sponsors may not notice right away until the interim analysis deadlines start to loom. And that’s when it becomes clear: the sites that best manage queries help sponsors stay on track.
That’s why it’s crucial to evaluate:
- How many queries are unanswered
- How long they remain open
- How quickly they’re closed
- How often they have to be re-opened
Together, these metrics show whether a site is accurate, responsive, and truly aligned with sponsor systems and expectations.
RDI’s study assessment results: At the time of the sponsor’s evaluation, RDI had just one query open, with an average closure time of 3.2 days. Even more importantly, nearly 90% of queries were resolved the first time.
Data Entry Timeliness: A Quiet Metric That Powers Real-Time Decision Making
Unlike enrollment or deviations, data entry speed doesn’t always get the spotlight. But sponsors know how critical it becomes when decisions depend on current data.
Whether it’s assessing patient safety, reviewing dose escalations, or preparing for DSMB updates, delayed data entry holds everything up. It forces reactive measures and erodes the sponsor’s ability to act proactively.
That’s why it’s important to track such performance metrics like:
- Total number of incomplete CRFs (excluding forms that aren’t yet due)
- % of CRFs completed within 14 days, which is the industry standard for timely entry
RDI’s study assessment results: At assessment time, RDI had 141 incomplete forms, all of which were within protocol-defined windows. Within the month of the assessment, 100% of the forms were completed within 14 days.
Strong Site Performance Metrics Tell a Deeper Story
When a site performs well across these four areas (enrollment, protocol compliance, query management, and data entry) the numbers speak for themselves. They reflect something deeper, too: a well-trained team, clear processes, consistent communication, and a culture that values collaborative efforts and excellence at every stage of trial execution.
In the case of this cardiovascular disease study, the sponsor’s structured performance review of RDI provided exactly what they needed: reassurance that the trial was in steady, capable hands.
If you’re managing a trial now or planning your next one, make sure you’re measuring what matters in your site performance evaluation and that your site partner is ready to deliver where it counts.