Post-market studies are investigations or examinations undertaken to assess the safety or performance of a medical device that is already on the market. A variety of study designs can be considered to collect clinical data, including registries, postmarketing studies, and other post-market studies that support Post Market Surveillance (PMS) programs. These include PMSS (Post Market Safety Study), Observational (Non-Interventional) Studies, Investigator-Initiated Studies (IIS), and Health Care Professional (HCP) Surveys.
Depending on the task, we select the appropriate study design and setup. Post-market studies are typically considered non-interventional, which is why central regulatory approval is generally not required; Ethics Committee approval is usually sufficient.
The main characteristics of post-market studies are that they typically involve more patients, sites, and countries. However, these studies are generally simpler than pivotal studies. The number of clinical parameters is usually reduced, the study design is less complex, and logistics are streamlined. Additionally, the number of monitoring visits can be reduced with sampled SDV (Source Data Verification) plans, and investigator fees are generally lower compared to those for pivotal studies.
Special attention should be paid to the data collection approach to ensure the efficiency and visibility of the study. The optimal solution is to use a validated electronic data collection (EDC) system, and for some study designs, ePRO/eCOA solutions. These systems simplify data collection at sites or directly from patients, as well as project monitoring, data cleaning, and data analysis.
The beauty of a post-market study is that it provides manufacturers with an opportunity to collect clinical data if such data is not available in the current device documentation. Notified Bodies allow the collection of clinical data through post-market studies to strengthen claims for products already on the market. This approach is a faster and more cost-effective way to gather clinical data and prepare for MDR re-certification.
Pharmaxi has conducted over 30 post-market and non-interventional studies. We understand the challenges in writing the CIP to ensure that a study is considered non-interventional. To avoid potential complications, it is essential that the study design is carefully reviewed to eliminate any interventional elements. Pharmaxi has connections with sites in more than 30 countries, enabling us to evaluate and include multiple sites worldwide to achieve the required results.
