PAES is an efficacy study requested by a Competent Authority in order to complement the available efficacy data.
A PAES may be imposed at the time of granting the initial marketing authorisation, in order to contribute in the resolution of some identified efficacy concerns that can only be resolved after the medicinal product has been marketed. A PAES, however, may be also imposed after marketing authorization granting, when the understanding of the disease or the clinical methodology or the use of the medicinal product under real-life conditions indicate that previous efficacy evaluations might have to be revised.
CORONIS clinical team can fully undertake the completion of the study and the submission of the final study report but also evaluate the impact of the final results on the marketing authorisation. Depending on evaluation’s results, CORONIS medical team will provide consultation on the proposed changes to the product information and update the PSUR with a summary of the clinically important efficacy and safety findings.