Services
Pharmacovigilance: Pre & Post Launch
Pharmacovigilance Solutions: (SAE) / (SUSAR)

Niche Pharmacovigilance and Signal Detection Solutions

  • 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