Pharmacovigilance Services

Stark Associates offers a broad range of drug safety services across the entire product lifecycle. With a team of qualified professionals and skilled experts we support your dug development in concise product safety profile compilation and risk mitigation plan until drug approval process.

Case Management
  • Receive cases from various sources
  • Case Initiation AE
  • Triage
  • Data Entry, MedDRA Coding
  • Adverse Event Labeling
  • Narrative Writing
  • Quality Check
Medical Review
  • Review source documentation
  • Confirm Seriousness
  • Confirm Expectedness
  • Review & Modify comments
  • Identify SUSAR/SUA’s
Medical/Safety Literature

Periodic search and review on:

  • Articles
  • Manuscripts
  • Abstracts
  • Excerpts
  • Bibliographic Searches for (ICSR)
Aggregate Report Development
  • Global Periodic Safety Reporting (PSUR, PADER, PBRER)
  • Provide support for ASR/DSUR
  • Review source data
  • Scientific/Medical Assessment of case
  • Medication Error and Drug Abuse/Misuse Reporting
  • Toxicology Report Management
  • Medical writing support for report generation
  • Risk management associated reports
Signal Detection and Analysis
  • Signal Generation and Detection
  • Signal Analysis
  • Determination of causality
  • Evaluation of frequency & strength