YOUR FIRST CHOICE FOR QUALITY, COST-EFFECTIVE ON-SITE MONITORING SERVICES Ensuring that your trial has quality data, is compliant with all applicable regulations, and meets all timelines is a must for success. Allow BMA field monitors to work with you and your clinical sites to help meet corporate and study timelines by providing monitoring support throughout all phases of a clinical trial. Our professional, industry experienced monitors will support your sites from feasibility through study closeout, as well as assist with audit preparation and submission support. - On-Site Monitoring Activities
- Certified Field Monitors
- Site Feasibility, Qualification & Selection Support
- Initiation, Interim and Closeout Visits
- Source Documentation Review & Data Verification
- Data Discrepancy/Query Support
- Regulatory Compliance Support & Review
- IRB Documentation Review
- Site Preparation for FDA & Sponsor Audits
- Participation & Presentation at Investigator Meetings
- Enrollment Review
- Identification & Addressing of Protocol Deviations & Violations
- Study Supply Inventory
- Reporting of Adverse Events & Serious Adverse Events
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