Accelerated execution enabled patient enrollment one year ahead of schedule

Situation

Emerald Clinical was engaged to provide CRO services for a global Phase III IgAN study spanning more than 100 sites across six countries. The sponsor required a partner capable of operating with speed, flexibility, and strong regulatory expertise to meet aggressive enrollment and timeline expectations.

Challenges

The study launched with a compressed timeline and an enrollment requirement that had to be achieved by a specific date. Emeraldʼs original recruitment target was >150 randomized patients by that date, placing significant pressure on site activation, screening, and enrollment performance.

Solutions

Emeraldʼs renal-focused teams approached the challenge with confidence, leveraging 25 years of experience, deep investigator relationships, and a proven track record of exceeding recruitment expectations across similar studies.

To mitigate risk and accelerate progress, Emerald
proactively expanded staffing and increased the number of participant sites beyond initial expectations. These efforts were guided by Emeraldʼs internal metrics and operational standards, which are more stringent than industry norms and refined through extensive prior experience. Site selection focused on centers with long-standing partnerships with Emerald and demonstrated access to strong IgAN patient populations. Consistent, proactive
communication kept sites engaged and ensured the study remained a priority.

Results

Emeraldʼs initial recruitment goal was “150 by specified date. By that date, the study had doubled randomized patients into the main cohort and additional patients into the exploratory cohort across over 100 activated sites, achieving these results in just eight months.

With Emerald Clinicalʼs experienced renal teams exceeding expectations for more than two decades — this IgAN study fully enrolled the patients one year ahead of schedule. The sponsor benefits with savings in time and money, but more importantly, could be getting better treatment for patients sooner.