Observational Pharmacovigilance:
ProSanos' Observational Pharmacovigilance methodology has evolved in response to
the challenge of using disparate and very large observational databases for the
purposes of drug safety monitoring. These databases include insurance claims
databases, as well as electronic health records databases, and typically represent
on the order of tens of millions of patient "lives". This methodology
has been codified into web-based software — SafetyWorks™.
With SafetyWorks, you can:
- Concurrently analyze multiple disparate observational data sources
- Analyze and incorporate detailed drug/condition context information for
overall population and subgroups of interest
- Apply multiple analytical methodologies to support identification and
evaluation of potential associations
- Enhance and support (supplement) the expertise of drug safety scientists to
make decisions based on the "preponderance of the evidence"
Benefits
- Construction of large cohorts with sufficient exposure to draw meaningful
comparisons
- Existence of "denominator" information allows the calculation of
multiple assessment metrics including: pre- and post-exposure incidence, target
versus background incidence, target versus comparator incidence
- Disparate data sources provide complementary perspectives
- Automated method supplements typical epidemiology support
Observational Pharmacovigilance Products and Services
- Observational pharmacovigilance services for in-depth analysis of a drug or
class of drugs using observational (Claims and/or electronic health record) data
- A license to access SafetyWorks software for in-house signal detection and
evaluation of observational data sources to supplement current pharmacovigilance
practices
