Case In Point
16,000-Patient, Global Respiratory Trial that was Findings Free
About Client
Everest was selected to provide critical data management and statistical services for a major pharmaceutical company’s global Phase III respiratory study. The study spanned 26 countries, 950 sites, and involved more than 16,000 patients screened and 8,500 randomized over 6 years.
Challenge
The trial’s scale and complexity posed significant operational and statistical challenges, including:
- Managing large volumes of global clinical data
- Ensuring consistency and quality across diverse geographies and clinical teams
- Delivering high-stakes data outputs for submission under tight timelines
- Maintaining quality and compliance throughout a lengthy multi-year trial
Solution
- Delivered Data Management, Biostatistics, Statistical Programming, IWRS, DSMB support, and CDISC data preparation
- Designed and launched the study database; provided exceptional CRA and site user training
- Executed a proactive data cleaning strategy with smooth soft-locks by site, country, and region
- Successfully managed DSMB activities to the highest quality standards
- Developed and adhered to rigorous SOPs and work instructions across teams
Results
- Final database lock completed within 2 weeks of Last Patient Last Visit
- Interim Analysis delivered successfully
- Top-line results finalized within 5 business days
- Multiple dry-runs enabled more than 1,000 analysis tables, listings, and figures delivered within 2 months of database lock
