Background
Clinical trials in anti-infective therapy areas are among the most challenging to deliver. Patients are often hospitalised, investigator workloads are heavy, and site engagement can fluctuate. One sponsor conducting a multicentre study across 17 sites in the United States found themselves falling drastically behind recruitment targets.
After five months, only 16 participants had been enrolled — less than half of the target of 43. The study was in danger of missing key milestones, delaying both data delivery and the sponsor’s ability to progress the treatment programme.
The Challenge
The therapy area itself was inherently complex, but the bigger problem lay in inconsistent site performance and communication gaps between investigators, monitors, and the CRO. Many sites felt disconnected from the study’s priorities, and the motivation to actively recruit eligible patients had diminished.
Micron’s Intervention
When Micron was brought on board, our priority was to stabilise the situation and rebuild confidence across the sites. Within days, our clinical operations team had reviewed all active sites, identifying where bottlenecks, procedural barriers, and morale issues were slowing progress.
We initiated direct engagement with investigators and coordinators — not just through reports, but through collaborative discussions focused on each site’s strengths and constraints. Our experienced monitors worked side-by-side with site teams to streamline screening, troubleshoot eligibility issues, and ensure investigators had clear, responsive points of contact.
Just as importantly, Micron refreshed the study’s operational rhythm. We re-established transparent communication lines with the sponsor, introduced proactive tracking metrics, and created short-term site-level recruitment goals that were both measurable and motivating.
The Result
Within the first month under Micron’s management, recruitment rates rebounded sharply — meeting the target of eight patients per month that had previously seemed out of reach. Subsequent months exceeded expectations, and full enrolment was achieved on schedule.
By transforming investigator engagement and applying hands-on site management, Micron not only met the numerical goals but re-energised the entire study network.
Outcome and Impact
A post-study review attributed the turnaround to Micron’s deep therapy-area expertise and our relationship-driven approach. Sites reported improved responsiveness, better communication, and renewed confidence in the study’s objectives.
The success demonstrated how targeted, collaborative site support can recover even the most at-risk trials — turning underperformance into momentum and restoring sponsor timelines without compromising quality.
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