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CLINICAL OPERATIONS
PROJECT MANAGEMENT
MEDICAL & SCIENTIFIC WRITING
QUALITY ASSURANCE SERVICES
REGULATORY AFFAIRS
PHARMACOVIGILANCE
Drug Safety Surveillance Services include:
Strategic planning
24 hours/seven days per week coverage
Clinical protocol program development
Adverse event coding
Post-marketing surveillance
SAE Processing
Regulatory report generation
Regulatory submissions support
Clinical Protocol Safety Section Development
Serious adverse event (SAE) processing
Safety evaluation and annual safety update services
Investigator/Site Training
Reconciliation Services - Safety/Clinical Databases
Regulatory Reporting (MedWatch, CIOMs)
Reports to Investigators/IRBs
Periodic Safety Update Reports (PSURs)
Annual Report
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MVG Consulting Services, Inc. | 40 Pearl Street | Braintree MA 02184 | 781-843-5491
© 2008 MVG Consulting Services, Inc.