Safety/PV signal analysis and remedial management

Many pharmaceutical and biotechnology companies have adopted a proactive approach to safety/PV data involving the systematic analysis of safety signals or patterns of adverse event data which may indicate unanticipated risks surrounding the product in specific patient populations.  Using large databases maintained by regulatory bodies to supplement the in-house database as well as specialized statistical techniques, e-Clinical partners can assist the sponsor staff to monitor for and evaluate such signals using experience in obtained in helping leading drug makers in establishing their signal programs.

If safety issues are revealed which force review of the licensure of a marketed product regulators may require specialized monitoring and reporting such as remedial evaluation method agreements.  We have been involved in negotiating and administering such agreements.