We, at NOMAD Life Sciences, offer a fully compliant and high quality complete package of pharmacovigilance services. Our Pharmacovigilance Services help you ensure regulatory compliance, enhance efficiency and reduce costs significantly. We provide solutions specific to the requirements of our customer's organisation and products.

NOMAD Life Sciences offer the following pharmacovigilance services

  • Clinical trial Pharmacovigilance:
From Phase I to IV we cover drug and vaccine safety right through the development cycle ensuring that ICH Good Clinical Practices are fulfilled. We have a passion to provide excellence and solutions for the services you require. Services include:
  1. Risk management strategies
  2. SAE's monitoring
  3. Expedited SAE reports
  4. SAE safety narratives
  5. Annual safety reports
  6. Safety databases
  7. Interim safety listings

  • Post Authorization:
It is our objective to ensure the risk-benefit profile of products is monitored, in order to maximise product potential, whilst ensuring patient safety. Regulatory authorities today expect greater assessment and analysis of AEs, as well as recommendations for increased safety surveillance monitoring to achieve earlier signal detection.

To assist companies during post-marketing surveillance, the Global Safety and Pharmacovigilance team:
  1. Creates customized programs for managing spontaneous AE reporting
  2. Transfers data electronically in compliance with ICH E2B (M2)
  3. Provides medical information services for literature review to detect signals and/or identify trends
  4. Prepares periodic safety update reports (PSURs)
  5. Assists in liability claims, causality assessments, and medical evaluations
  6. Reviews and assesses in-house safety data
  7. Reviews labeling modifications (SmPC variations) for consistency with safety data
  8. Prepares and reviews risk/crisis management strategies
  9. Analyzes epidemiologic data to determine strategies for signal detection in safety-surveillance studies and to establish registries for continuous safety monitoring
  10. Conducts workshops and courses on pharmacovigilance requirements
Designs, reviews, and implements risk-management plans and safety surveillance studies to include cohort, case-control, post-marketing surveys (simplified Phase IV), registries and data base studies

  • Medical Device Vigilance:
  1. Medical Device Consultancy and Project Management
  2. Adverse Device Effect (ADE) / Medical Device Incident (MDI) Case Processing, coding and follow-up
  3. Case Narratives
  4. Safety Data Management & Global Safety Database
  5. Signal Detection & Evaluation
  6. Device Vigilance Report Preparation & Submission
  7. Medical assessment
  8. Literature Search & Review
  9. Vigilance Quality Assurance including SOP development
  10. Monthly compliance and status reporting
  11. ADE and MDI Reconciliation
  12. Field Safety Corrective Action (FSCA) generation and submission
  13. Creation and distribution of Field Safety Notices (FSNs)
  14. Periodic reporting