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Study Management Services
Clinical Trial Monitoring
Boston MedTech CRO provides comprehensive, high-quality clinical monitoring throughout the entire clinical trial process. Our certified Clinical Research Associates observe and examine all aspects of the study, from site initiation to study closeout, ensuring the quality and integrity of the study data in compliance with FDA regulations and GCP/ICH guidelines.
Clinical monitoring activities include:
- Site screening and qualification visits
- Development of monitoring manual
- Pre-study and site initiation visits
- On-site protocol training for study personnel
- Subject eligibility and recruitment
- Periodic monitoring visits throughout the clinical trial
- Home monitoring visits
- Data and source document review and collection
- Query generation and resolution
- Adverse event reporting
- Protocol deviation management
- Inter-site coordination to more efficiently achieve the clinical trial’s target goals
- Investigator compliance monitoring
- Device tracking and accountability
- Study closeout visit