Niche Pharmacovigilance and Signal Detection Solutions

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• Global Regulatory Pharmacovigilance provider

• Safety database services

• SAE/SUSAR case processing

• Adverse Event (AE) data intake for Signal Detection

  • Global intake for international development programs​

• DSUR/CSR/ISS/ISA/Benefit Risk Assessment/IB/ICF

• Signal Detection Expertise

  • Rare disease programs​

  • Gene therapy studies

  • Small denominator programs w/noise reduction needs

• Centralized High Specificity Coding Practices

  • MedDRA, WHO-DD

• Global Medical Monitoring and Safety Physician Services

• Case Narrative Processing

• Global Regulatory Support and Intelligence

• Regulatory Literature Search Services

• EudraVigilance and Global Case Reporting

• Safety Medical Writing

• Medical Information Support

• Spontaneous report processing

• Clinical and regulatory review

• Safety SOPs

• Comprehensive Safety Reporting program, drugs and devices.

• Quality PV Systems

• PV Training