Key Highlights
Exceeding Recruitment Targets in a Proof-of-Concept Asthma Study
Clarenta supported a randomized, double-blind, placebo-controlled Phase II Proof-of-Concept study evaluating the efficacy, safety and tolerability of an investigational oral therapy in adults with moderate-to-severe asthma.
We provided patient recruitment and clinical monitoring support across three activated clinical trial sites in Bulgaria operating within a competitive global recruitment model.
The Challenge:
The study followed a competitive recruitment model involving multiple clinical trial sites. Enrollment depended on each site’s ability to identify eligible participants and recruit them before the global target was reached.
The study presented several operational challenges:
- Eligible adults with moderate-to-severe asthma had to be identified efficiently
- Recruitment performance needed to be coordinated across three Bulgarian sites
- Participating sites required continuous operational support
- Recruitment progress needed to be monitored closely
- Communication among investigators, site personnel and the wider study team needed to remain consistent
- Clinical monitoring activities had to continue alongside accelerated recruitment
Our Solution:
We implemented a coordinated recruitment and clinical monitoring model across the three activated sites.
Our team:
- Supported the identification and screening of potentially eligible participants
- Coordinated patient recruitment activities across the participating sites
- Monitored recruitment performance against site-level targets
- Maintained regular communication with investigators and site personnel
- Provided ongoing operational support throughout study delivery
- Conducted clinical monitoring activities across the Bulgarian sites
- Identified and addressed site-level recruitment needs
- Maintained alignment among the participating sites and wider study team
The Outcome:
The three Bulgarian sites enrolled 48 participants in the Phase II Proof-of-Concept study.
The leading site enrolled 29 participants against a contractual target of 15, exceeding its target by 93%.
The study was successfully completed, contributing clinical data on the efficacy, safety and tolerability of the investigational oral therapy.