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Indero supported the rescue of a Phase 2a atopic dermatitis trial.
Outcomes
Indero successfully rescued this AD study, resulting in:
215% enrollment increase in half the time
Dramatic improvement of site engagement
Study Characteristics
- Study Phase: 2a
- Patient population: Atopic dermatitis
- IP Route of administration: Systemic
- Initial Sites Distribution: 27 in 1 country (US)
- Post-rescue final site distribution: 30 (kept 15 from original selection) in Europe and North America
Study Challenges and Solutions
Challenge #1
Patient Recruitment Concerns & Poor Site Management:
- Enrollment struggles led to trial delays
- Significant site payment delays
- Lack of site support and training
Solutions
- Indero’s enhanced outreach and strategic partnerships with additional sites and patient advocacy groups boosted enrollment
- Manual work done to accelerate payment processes and satisfy sites’ needs
Outcome
- Recruitment triumph: Achieved 215% enrollment increase in half the time
- Sites relations: Dramatic improvement with Indero’s involvement, re-engaging disengaged sites
Challenge #2
Data Oversight Issues:
- Significant 6-month data cleaning backlog, potentially causing data inaccuracies
Solution
- Data cleaning achieved through Indero’s rigorous and extensive monitoring, ensuring unparalleled quality
Challenge #3
Missed Deadlines:
- Operational inefficiencies derailed the schedule
Solution
- Comprehensive restructuring by Indero improved coordination and adherence to timelines
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