Pharmacovigilance

Drug Safety or Pharmacovigilance or Medical Safety is an integral part of the clinical trials, where we monitor the adverse events (AE) and the serious adverse events (SAE) that may occur to volunteer on trials by the drug.

At Katalyst HLS, we consider volunteer safety the highest priority when conducting clinical trials. We adhere to the strictest standards in our study conduct and provide critical expertise through the experienced MDs and other qualified medical safety personnel in our Medical Safety or Drug Safety department.

Patient Safety Monitoring and Compliance

Patient safety in clinical trials is continuously monitored and subject to legally binding reporting requirements. All adverse events experienced by a clinical trial patient are recorded on the clinical trial report forms and are collected, monitored, and managed by safety system software like oracle Argus, ARISg, and other tools.

All events are documented whether they are considered related or not to the study drug. Some of these events are considered serious adverse events (SAEs) if they meet certain criteria, most typically hospitalization. All the serious adverse events are reported by the hospital staff within 24 hours to the sponsor of the trial.

Pharmacovigilance and Drug Safety Services

Individual Case Management

  • Data entry and triage
  • Case coding
  • Narrative writing
  • Quality control
  • Reporting

Aggregate Safety Reports

  • Periodic Safety Update Reports (PSUR)
  • Benefit-risk evaluation report (PBRER)
  • Periodic Adverse Drug Experience Report (PADER)
  • Investigational New Drug (IND) – Annual Report
  • Developmental Safety Update Report (DSUR)

Risk Management Plan

  • Risk management planning
  • Risk management plan development
  • Development of risk minimization
  • Assessment of risk minimization
  • Risk management studies

Signal Detection

  • Signal Detection, Prioritization
  • Statistical Analysis in Large
  • Adverse Event Databases
  • Active Surveillance
  • Signal Assessment using Pharmacovigilance database

Medical Call Center

  • Adverse events
  • Product complaints
  • Medical information
  • 24 X 7 Safety Coverage

Others

  • Literature search and medical information
  • QPPV Support
  • Inspection and Audit support
  • Physical retrieval of damaged products and analysis
  • PV Consultancy/Advice
  • PV Training