Innovative Operational Approach
Our pharmacovigilance department operationally supports our peri-approval services by offering quarterly and periodic aggregate reports, trending analysis and ad hoc safety signal analyses, in addition to the review of solicited and spontaneously reported adverse drug reaction case data.
We offer expert consulting on the design and implementation of risk evaluation and mitigation strategies (REMS) and risk management plans (RMPS) with a niche skill set in global execution of integrated solutions, given the distinct differences between the major regulators in this area.
We also serve as the safety department for companies lacking their own in-house resources and confidently manage the transition of IND compounds to marketed products. We can interface seamlessly with your drug information services or provide you with an integrated solution of our own.
Complete marketed product support services:
- Post-marketing surveillance
- SADR, spontaneous ADR processing and reporting
- Serious adverse event (SAE) processing and reporting
- Registries, phase IV trials
- Lab and diagnostic test review
- Periodic safety update reports (PSUR), annual and quarterly report preparation
- Signal detection services
- Trending analyses for labeling changes
- Argus™ safety database
- REMS/RMP design and advisory consultation