The monitoring of the safety of medicinal products is a key concern throughout the product's lifecycle. At the time of product launch, drugs will have been tested on, at most, only a few thousand patients. This very fact is a concern to the EMEA, the FDA, and other regulatory agencies. For this reason, the Marketing Authorization Holder should be proactively minimising this concern. Indeed, a commitment to implementing additional Pharmacovigilance activities as part of risk management is becoming the norm rather than the exception.
Routine Pharmacovigilance is a useful tool for identifying potential safety concerns but because rates of reporting are so low, it is unlikely to be able to identify rare signals until the product has been on the market for some time. A Phase IV clinical trial is the appropriate study design for the formal testing and evaluation of a known safety issue whilst observational study provide a number of options for observing cohorts of patients over a extended period of time to identify both short and long-term safety issues of a product.
PACE and the PAREXEL Pharmacovigilance Services group work together to offer our clients a global safety study capability, with the experience to help you decide what kind of study should be conducted, the regulatory and ethical requirements in each country and a full reporting and management system so that you can be assured that your study is in our safe hands.
For more information, contact the PACE Group.
We are a leading global bio/pharmaceutical services organization that helps clients expedite time-to-market through our development and launch services. These include a broad range of clinical development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialization services.