Post Marketing surveillance and Phase IV studies
Postmarketing surveillance (PMS) involves monitoring the safety of a pharmaceutical drug or device after it has been released on the market. It is an essential part of the pharmacovigilance process. The protocols are implemented after a drug has been licensed for public use and are designed to provide information on use and on occurrence of side effects, adverse effects, real world usage etc.
Despite the rigorous review of drug safety data during the licensing process, active postmarketing surveillance of drug adverse effects is also essential. 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.
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.
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.
A high level overview of our services in this area are available for download as a PDF via the following link : Post Marketing Studies