Pharmacovigilance
The quality of your drug safety team is of the highest importance. That’s why you need an experienced and committed partner who commands the regulatory landscape with confidence. Our global and scalable safety solutions are designed to be efficient, affordable, and fully compliant, giving you flexibility and peace of mind in a complex clinical environment.
Experience you can count on
Don’t put your safety at risk with underqualified or poorly resourced groups. Our unique resourcing methodology means every team has senior-level safety specialists with 10+ years of experience. All team members are based within the US for consistent available, accessibility, and accountability. With industry-low <6% company turnover vs 25-30% standard CRO attrition, you’ll get unparalleled continuity across the lifecycle of your program.
Unique pricing approach
The standard unit-based models can prematurely drain a program’s budget. Our unique model is customizable and allows for greater cost savings and predictability.
Expert users in industry-leading safety database
With deep experience in Argus, our teams can deliver real-time data outputs and legacy safety data migration.
Process built for operational and cost efficiency
In drug safety and pharmacovigilance, collaboration isn’t just a buzzword—it’s an essential component that can impact patients and the success of your product. We prioritize collaboration and communication between cross-functional global stakeholders.
inSeption Group Safety Solutions and Services
- Triaging, processing, and reporting of serious adverse events (SAEs)
- Expedited reporting to Regulatory Authorities and Central IRBs/Ethics Committees
- Cross-reporting of safety data to developmental partners/vendors
- Development and maintenance of a customized safety management plan with continuous optimization
- SAE reconciliation between the Argus safety database and EDC systems
- Compound-level aggregate safety reports (ISS, DSUR, PDUR, PBRER, etc)
- Narrative writing
- Ad hoc safety staffing
- Management of safety vendor transition with accelerated implementation, if needed
Hear our experts talk about trusting inSeption Group
Let’s talk safety.
Get in touch to find out more about why inSeption is the safety champion your program needs. Contact us.