Clinical Monitoring
Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site monitoring visits throughout the study to:
- Oversee data collection
- Review source documentation and case report forms
- Ensure regulatory compliance
- Resolve data queries
- Conduct interim analyses as requested by clients
Clinical Research Associates (CRAs)
PPD is dedicated to employing and retaining top-notch CRAs who:
- Are required to successfully complete a residential U.S. Food and Drug Administration (FDA)-accredited foundation program
- Have demonstrated site monitoring proficiency to PPD management before being allocated to a study
- Are typically dedicated to one protocol at a time to maintain quality
- In Europe and Asia, are assigned to monitor sites in their home countries, providing understanding of local languages, regulations, customs and business practices