Clinical Trials and Device Monitoring Services
Disease Experience
Clinical Trials and Device Monitoring Services
- On-Site visits (selection, initiation, monitoring, termination, post marketing approval safety monitoring)
- Phases I-V Clinical Drug Trials
- Post- Marketing Safety Surveillance
- Class II/III Device Trials
- Risk Based Monitoring
- e-TMF and CTMS maintenance
- Centralized remote monitoring and Site Management
- Ensure adherence to FDA and ICH-GCP regulations
- Ensure adherence to local regulations
- Ensure completion and collection of regulatory documents
- Teach site staff about their roles and responsibilities in conducting clinical trials
- Evaluate and report site performance and protocol compliance
- Perform product accountability and supply tracking
- Ensure completion and collection of Serious Adverse Events (SAEs)
- Assist with data validation and query resolution