We provide a comprehensive plan to help you manage your pre- and post-marketed product safety program. Our services include:
SAE/AE Handling
Adverse event (AE) and serious adverse event (SAE) data entry and logging
Current treatment utilization patterns
Disease burden and prevalence
Data Management
AE and SAE logging, tracking, coding
and case processing
MedDRA and WHO-DD coding
Medical Analysis
AE and SAE evaluations
SAE narrative writing
Physician medical review and signal detection
Literature reviews and summaries
Regulatory Reporting
Generation of MedWatch 3500A/CIOMS I forms
Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)
Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports
Electronic Adverse Event Reporting
We have the flexibility to use our clients’ proprietary or licensed electronic reporting systems, or we can use Argus Safety™, a leading technology for SAE and AE case management and reporting. Our Argus Safety license allows us to provide a fully validated 21 CFR Part 11 compliant system that can be customized to meet your needs.
End-User Focused Approach
We follow the FDA's Good Pharmacovigilance Practices and EMEA's European Directive 2001/20/EC guidelines and focus our work-products on the end-user perspective.
