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!
Innovations in Global Clinical Trials
- Course Type: Webinar Replay
- Language: English
- Level: Advanced
- Session: year 2020
- Time: 1 - 3 Hours
|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|
Exam and Certifications
- Final Test – INNOVATIONS IN GLOBAL CLINICAL TRIALS
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.
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