Epidemiological surveillance is the discipline of continuously gathering, analyzing and interpreting data about diseases and disseminating conclusions of the analyses to relevant organizations.
Post marketing surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug or device after it has been relapsed on the market and is an important part of the science of Pharmacovigilance.
Post-marketing surveillance is important because at the time a drug is approved for marketing a number of clinically and epidemiologically important questions are unanswered. Post-marketing surveillance of drugs therefore plays an important role to discover undesirable effects that might present a risk. Post-marketing surveillance studies provide additional information on the benefits and risks of a drug, resulting in possible drug safety hazards being identified which impact on, or may influence the overall benefit/risk ratio of a medicinal product.
PMS used as a number of approaches to monitor the safety of license drugs including spontaneous reporting databases, prescription event monitoring , electronic health records, patient registries and record linkage between health databases.
Our services dedicated, the field phase of the PMS/PASS (Post authorized Safety Studies) may be conducted by the sponsors/ CROs own sales representatives with SCR team and managed by trained and enthused staff coordinators.