Postmarketing surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs are approved on the basis of clinical trials which involve relatively small numbers of people who have been selected for this purpose - meaning that they normally do not have other medical conditions which may exist in the general population - and postmarketing surveillance can further refine, or confirm or deny, the safety of a drug after it is used in the general population by large numbers of people who have a wide variety of medical conditions.

Postmarketing surveillance uses a number of approaches to monitor the safety of licensed drugs, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries and record linkage between health databases. These data are reviewed to highlight potential safety concerns in a process known as data mining.

We have expertise in conducting large scale cohort studies on drug safety, adherence, risk management and postmarketing surveillance. Using controlled prospective long-term and non-interventional methodologies we can recruit cohorts of 20,000+ patients and continue to follow them up over the course of a set timeframe, from 2 years to more than 10 years.

Data is quality controlled, overall loss to follow up kept within low margins and our service also offers to carry out any necessary validation of self-reported adverse events.

We can also offer assistance in gaining any required ethical approval for the study and all our employees are fully trained on the importance of data protection and confidentiality.

All our studies in this environment are conducted according to Good Epidemiological Practice (GEP); Guidelines for Good Pharmacoepidemiology Practices (GPP) and the Declaration of Helsinki.

Medicys has created a large international network of primary and secondary care physicians who contribute to our projects by enrolling patients in our studies.

Any PMS relies heavily on the data acquired from patients at baseline, but also, crucially, in subsequent follow-ups and Medicys applies a multi-faceted, four level follow up process to minimise  the “loss to follow up” rate to 5% or less over a 5 year period.

To see examples of our recent Post Marketing Study projects, click the link below:

Recent Projects