A complete guide to navigating US data regulations and corresponding solutions.
Working within the regulated field of clinical trials can be challenging, especially when contending with regulatory authorities, rules and challenges.
We’ve collated the relevant rules and broken these down into how these impact the longterm management of your clinical data, including those stipulated by the:
- FDA
- CGMP and Good Clinical Practice
- ICH Guideline for Good Clinical Practice E6 R2
- GDPR.
You can download this guide for free using the below form.
Suggested reading
02 Nov, 2021
A Guide to EU GCP Data Management Regulations
Neuraly Case Study: Helping a revolutionary clinical-stage biotechnology company become GCP compliant
16 Sep, 2021