Phase II-IIIb
ICON provides a range of integrated services that cover the planning, management, execution and analysis of Phase II – IIIb trials.
Clinical Development Support
Patient-reported data is an important source of information in registration studies. We provide multiple services supporting Phase I–III global clinical trials:
- Development and Validation of Patient Reported Outcomes (PROs)
- Translation and Cultural Adaptation of PROs to be included in clinical trials
- PRO dossier and document submissions for the FDA
- Selection of Endpoints for Patient or Economic Outcomes
- PRO Data Collection (electronic and paper)
- Data Analysis of PRO and Economic Endpoints
- Site Support for PRO data collection
- ROC analysis for PMAs