Services
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 Sales at sales@druglogic.com, if you have questions about any of our services.