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
