We have global experience managing projects directly and providing oversight of a CROs work across multiple therapeutic areas in phases I-IV clinical, device, and consumer goods research studies/trials. Vast experience in numerous EDC platforms and associated clinical research software. Clinical Data Management Offerings include:
- Protocol and statistical analysis plan contributions
- Strategic planning and execution
- Database and edit check design including managing database modifications as required
- Ongoing data cleaning
- Document development (DMP, DRP, DTA, etc.)
- Project management
- Medical coding
- Local laboratory management
Because of our years of experience, we can offer the best practices in data collection and review with focus on specific study endpoints. We also have deep experience in study rescue situations where timelines are critical.