Safeguarding public health and confidence
Division: Epidemiology | Locations: London, Hamburg, Washington DC
Preserving health and maintaining public confidence.
Early detection of adverse drug reactions (ADRs), manufacturing defects and unexpected adverse outcomes is a crucial component of protecting public health and preserving public confidence in medicines and biologicals. CBRD's pharmacovigilance expertise can assist in finding safety signals in both active and passive reporting systems, evaluate pharmacovigilance datasets, analyse safety data from clinical trials and Phase IV post-marketing surveillance and prepare submissions for regulatory purposes.
Evaluation of existing
Regular audits of SOPs, reporting lines, alarm plans and ensuring that the Pharmacovigilance System Master File (PSMF) complies with relevant EU, national and other legislations.
Preparing materials for
A thorough analysis of all safety data from clinical trials, as well as the PSMF and other relevant documents, are collated in an effective and appropriate format for regulatory scrutiny.
Setting up custom
Where a custom reporting or prescription registry system is mandated by the regulator or otherwise deemed advisable, CBRD's pharmacovigilance system engineers can provide an easy-to-use, web-based reporting service and initiate the appropriate processes.
Signal generation &
analysis of passive reporting
Passive reporting systems, such as VAERS, present a range of difficulties when it comes to analysing data and deriving actionable information. CBRD's pharmacovigilance experts can assist in using computational methods to isolate potential safety signals.