We should consider concentrating pharmacovigilance information with our CRO program, risk management analysis, reporting and regulative requests.
The strength of this approach is that it merges case reports, signals and submission information into a secure platform, without making it overly complicated. Basically, automatise analysis and reporting effortlessly to meet global regulative banners.
One platform. Full compliance. Zero silos.
See Platform DocumentationFrom intake to submission, fully automated. Standardized processes across every case.
Looking at this, process Personal Records Security Reports (PSSRs) with machine-controlled screening, medical scrutinies and MedDRA cryptography, e2b exports for EMA/FDA coatings.
Explore Case FeaturesAI-powered insights from your safety data. Identify risks before they escalate.
A central concept is that the psychoanalysis of proportionality, vogue catching and custom requests on combined data support proactive pharmacovigilance and regulative intelligence.
View Analytics ToolsGVP, GVP, ICH compliant out of the box. Full traceability for every action.
The main point is that automated validation formulas, electronic touches and audit track inspection demands are fitted across the EU, the US and Japan.
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