Difficult to Recruit Population
Global Processes
Data Management
Recruiting
Need
- Required a study targeting a difficult to recruit therapeutic patient group
Approach
- Developed a creative strategy to split recruiting and dosing of this study at Celerion clinics in two geographical locations
- Multi site approach enabled on-time recruitment for this niche patient group
- Executed clinical conduct almost in parallel using identical processes, enabled by global processes employed by Celerion
- Required only one Case Report Form (CRF) template and Data Management Plan
- Conducted Data Management activities from two different locations on one centralized server using the same process flows while adhering to global Standard Operating Procedures (SOPs)
Benefits
- Creative use of recruiting and dosing at multi sites enabled Celerion to deliver a database within the clients’s timeline expectations