MEDICAL MONITORING

Provide Medical Monitoring and support to Project Team/Sites (enrollment)

Provide Medical Monitoring and support to Project Team/Sites (treatment)

Conduct Medical / Safety review of CRFs

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SAFETY MANAGEMENT

Safety Review Committee Meetings Organization and Management

Develop SAE Management Plan

Create Safety database (set up, validation, maintenance)

Develop SAE tracking system

Execute SAE Reporting

Conduct SAE Medical Review, Follow-up and Documentation

Perform SAE reconciliation with Investigators, Ethics Committee and Health Authorities

Perform Final SAEs reconciliation with Sponsor

CIOMS Forms Submission and Management

Annual Safety Reporting (DSUR) to Country-Level Agency

Annual Safety Reporting (DSUR) to IRB

Annual Safety Reporting (DSUR) to Investigators

Provide On-going Medical Monitoring and Safety Monitoring Support 

• Attend team meetings

• Advise on medical and safety topics

• Attend meetings with partners

• Produce materials for investor or business development presentations