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
A complete guide to navigating long-term EU GCP data regulations and corresponding solutions. Working within the regulated field of clinical trials can be challenging, especially when contending…
20 Apr, 2021
Neuraly Case Study: Helping a revolutionary clinical-stage biotechnology company become GCP compliant
You can access the full Neuraly case study here. With two clinical studies in Phase II and three more in pre-clinical stages, Neuraly – a clinical-stage biotechnology…
16 Sep, 2021
Data Archiving Supplier Checklist: The key questions you need to ask prospective suppliers
Making the decision on whether to build your archiving solution in-house or work with a third-party isn’t always easy, but if you find yourself in this predicament,…