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Outcomes
Indero successfully rescued this AD study and this resulted in:
215% enrollment increase in half the time.
Dramatic improvement of sites’ engagement.
Study Characteristics
- Study Phase: IIa
- Patient Population: Atopic Dermatitis
- IP Route of Administration: Systemic
- Initial Sites Distribution: 27 in 1 country (US)
- Post Rescue Final Sites Distribution: 30 (kept 15 from the original selection) in 2 continents (Europe and North America)
Study Challenges and Solutions
Challenges #1
Patient Recruitment Concerns & Poor Site Management:
- Enrollment struggles led to trial delays
- Significant site payment delays and lack of site support and training
Solutions
- Enhanced outreach and strategic partnerships with additional sites and patients advocacy groups boosted enrollment
- Manual work done to accelerate payment processes and satisfy sites’ needs
Outcome
- Recruitment Triumph – Achieved 215% increase in half the time
- Sites relation – Dramatic improvement with Indero takeover, re-engaging disengaged sites
Challenge #2
Data Oversight Issues:
Significant 6-month data cleaning backlog potentially causing data inaccuracies
Solution
Achieved through rigorous and extensive monitoring, ensuring unparalleled quality
Challenge #3
Missed Deadlines:
Operational inefficiencies derailed the schedule
Solution
Comprehensive restructuration became the trial’s saving grace to improve coordination and adherence to timelines
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