Clinical Research Operations

The Clinical Operations function is a critical component in all studies. From start-up to close-out, our highly-skilled clinical operations consultants ensure proper planning, study conduct, patient safety and data quality, while fostering good communication between study sites and sponsors. MVG Consulting Clinical Trial Managers provide leadership and operational expertise through collaborative planning, implementation and execution.

Overview

• SOP Development
• Protocol Development & Review
• CRF Design
• Informed Consent Form Development
• Investigator Recruitment
• Site Selection
• Regulatory Document Collection
• Site Training
• Investigator Meeting Planning
• Clinical Monitoring (Qualifications, Initiation, Interim, and Close-out visits)
• AE/SAE Reconciliation
• Drug/Device Accountability