Clinical Data for IVD: What is it and How Do I Find It?
Do you have questions about how to generate, collect, analyze, or assess clinical data pertaining to your IVD? What are the best practices for conducting literature searches? How do you effectively present your data in your performance evaluation report? Whether you are just beginning your PER preparations or are already in the process of writing, we will provide insights and suggestions to help make the process of data collection, extraction, and presentation more streamlined.
This forum answers question like these and more. Click here to watch the recording.
Who watch this forum?
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve performance evaluation reports for IVDR submissions.
A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness
The implementation of IVDR requirements has challenged IVD manufacturers to align their internal processes and systems with these rigorous regulations. Therefore, companies realize reviewing published literature for device-specific clinical data to establish the state-of-the-art (scientific validity) is imperative. In addition, establishing clinical performance of their products is key. However, many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR). Finally, screening, selection and data extraction are typically challenges for manufacturers as well.
In this presentation we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Next, using case studies, we illustrate the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
- Review the essential steps for conducting a robust, methodologically-sound systematic literature review
- Using a typical case study scenario, learn how to effectively search, identify, screen, review and extract critical published clinical data on your subject IVD device to support the development of the Scientific Validity and Clinical Performance Reports.
Watch this webinar recording.