DrugLogic can provide an array of reports to satistfy our customers needs.

Risk Management and Trending Analysis

  • Case count progression
  • Percentages of reactions or concomitant drugs
  • Trending analyses for other trended areas of interest

Safety Surveillance Reporting

Investigative Drug Reports

  • Comprehensively analyze drug-reaction pairs with high reporting rates
  • Investigative groups of reactions, eg. DMEs, CMQs, medical concepts or syndromes

Investigative Reaction Reports

Drug-Drug Interaction (DDI) Reports

Quarterly Flash Reports

Surveillance/Signaling Reports

  • Complications and integrated summaries
  • Signal detection reports and signal evaluation reports
  • Periodic Safety Update Reports (PSURs)

Risk Management and Pharmacovigilance Consulting

Development of pharmacovigilance workflows and supporting SOPs

Design of Risk Management programs

  • Safety specifications and pharmacovigilance plans
  • Risk management monitoring programs
  • REMS and RiskMAP documents

Development of product-specific processes for signaling and surveillance

Development of proprietary DME lists and proprietary indication lists

Research and expert testimony for product defense

Customized risk management summaries and ongoing monitoring reports

Please contact Steve Wordham at Steve Wordham email if you have questions about any of our services.