Clinical Evidence and Post Market Surveillance (PMS)
If there is one topic that will dominate the healthcare sector over the next decade, it is that of how justification is required to keep products in the market. The requirement for this can already be seen in the proposed text of new European Regulations for Medical Devices and In Vitro Diagnostics, which will drive the industry in this direction. Strong clinical evidence will now be necessary to back up the performance of products.
ABC can help you compile the information that you will need to ensure the longevity and profitability of your products. We can show you what data you need, how to get it and how to analyse it effectively. An appropriate program of clinical research and data gathering is critical to meeting these requirements. Let us help you develop strategies for clinical data, and other internal metrics, to keep you ahead of the competition.
Clinical Evaluation Reports
These are critical documents that need to be periodically refreshed to demonstrate that products should be allowed to continue being distributed across many territories. They are generated following guidance such as MEDDEV 2.7.1 "Clinical Evaluation: A Guide for Manufacturers and Notified Bodies" and draw from multiple data sources such as complaints and registry data. We have a broad experience in the authorship of these documents for Class III products such as orthopaedic implants, as well as other devices like drug delivery systems.
Clinical Strategy & Protocols
We are able to support the development of clinical strategies appropriate for your products using experienced clinical research specialists. For example, this could include the development of protocols, identification of study sites, ethics approvals, data management/analysis and study reports.
Medical Professional Input
We have extensive access to support from relevant medical professionals for the review and approval of protocols and Clinical Evidence Reports (CER). This is a vital component of every company's ongoing regulatory compliance.