INNOVATIONS IN CLINICAL TRIALS WITH ISO 14155 IN THE ERA OF COVID-19
August 3rd, 2020
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.
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!
The speaker, Dr. Monica Tocchi, is a clinician and expert of the Technical Committee that developed the new ISO 14155.
White paper download: Impact of ISO 14155 on clinical trials in the Covid-19 Era
Get this paper to learn the innovations in clinical trials:
- Covid-19 and explosion in digital health
- Innovation in clinical trials
- The digital revolution
- Impact of the new ISO 14155
- The future of clinical research