Post-Market studies are investigations or examinations undertaken to assess the safety or the performance of a medical device that is already on the market. The variety of the study designs could be considered to collect clinical data. These are registries, postmarketing studies, and other post-market studies that support Post Market Surveillance (PMS) programs ie., PMSS - Post Market Safety Study, Observational (Non-Interventional) Study, Investigator Initiated Study (IIS), and Health Care Professional (HCP) Surveys.
Depending on the task, we choose a proper study design and study setup. The Post-Market study is usually considered non-interventional. That is why central regulatory approval is not required and the Ethics committee approval is sufficient in general.
The main specifics of Post-Market studies are that they usually embrace more patients, sites, and countries. At the same time, these studies are simpler than pivotal studies. The number of clinical parameters is usually reduced, the study design is not complex and logistics are also simplified. The number of monitoring visits could be also reduced with sampled SDV plans and investigator fees are usually much smaller than for Pivotal studies.
Special attention should be paid to the data collection approach to ensure efficiency and visibility of the study. The optimal solution is the usage of a validated electronic data collection (EDC) system and, with some study designs, ePRO/eCOA solutions. Such systems simplify data collection at sites or directly from patients, project monitoring, data cleaning, and data analysis.
The beauty of Post-Market study is that it is a chance for manufacturers to collect clinical data if those data are not available in the current device documentation. Notified Bodies allow collecting clinical data to strengthen claims for products which are already on the market using a Post-Market study. It is a faster and cheaper way to collect clinical data and be ready for MDR re-certification.
Pharmaxi has performed 30+ Post-Market and non-interventional studies. We know challenges in writing the CIP to ensurea study is considered non-interventional. To avoid possible complications, the study design should be clearly examined in order to avoid any interventional signs. Pharmaxi has connections with sites in more than 30 countries and therefore we are able to evaluate and include multiple sites worldwide to achieve the results required.