- Introduction (00:03:49)
- ISO for COVID-19 (00:01:56)
- ISO 14155-EXPANDED SCOPE (00:06:08)
- ISO 14155-CLINICAL TRIALS (00:05:34)
- INNOVATION IN CLINICAL TRIALS (00:01:57)
- TAKE HOME MESSAGE (00:03:10)
INNOVATIONS IN GLOBAL CLINICAL TRIALS
This webinar provides an overview of the innovations in clinical trials and provides practical suggestions on how to get ready now – as the standard is already effective and everyone is expected to comply!
Clinical trials are essential for the advancement of medical science. In fact, these research studies are necessary for determining the safety and effectiveness of new drugs, vaccines, surgical procedures, medical devices and diagnostic tests.
A new international standard on clinical investigations for medical devices developed by the International Organization for Standardization (ISO) has been released in July 2020. The new standard, ISO 14155:2020, introduces key innovations that will allow Sponsors to run better trials, not only for market approval of medical devices and in-vitro diagnostics, but also to collect more evidence when your device is placed on the market.
Knowing this standard is fundamental today, when we consider the increasing demand of value-based evidence, the explosion of digital health, and the new modalities for virtual trials and real-world evidence.
The 2020 revision of ISO 14155 is a truly transformative regulation that will allow sponsors to run trials anywhere in the world. By following this standard, sponsors will be able to select the best sites for the investigation in any geography and generate data that will be accepted by the US FDA and also by European and Asian regulatory authorities. In fact, the standard has been aligned with the new European Medical Device Regulation, US FDA regulations and global requirements, enabling seamless compliance and removing barriers to scientific progress. This standard is also aligned with pharma requirements and therefore, it’s helpful for trials of combination products.
- Final Test – INNOVATIONS IN GLOBAL CLINICAL TRIALS
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