Regulatory & Compliance Journey

Hear tips and strategies to mitigate risk and keep your studies in compliance.

 
Featured
Building an Integrated Clinical Evidence Strategy for Medical Device R&D
How the New Single IRB Requirements Will Change Clinical Research
Compensating Research Subjects: The Fine Line Between Fairness and Inducement
The Clinical Research Technology Reboot: Are We Getting it Right?
European Data Privacy Roadmap: Balancing Research, Innovation, and Compliance
ICH E6(R3): Real-World Questions & Answers
Comparing and Contrasting Approaches to In Vitro Diagnostics Research vs. Other Medical Devices
Your Guide to 21 CFR Part 11 and Annex 11 Compliance
Inspection Readiness: It's All About the Data
FDA's Latest Guidance on Informed Consent: Reading Between the Lines
Principles to Practice: An Understanding of the ICH E6(R3) Update’s Effect on Good Clinical Practice
CANCELED—FEAR: Face Everything and Rise (in Clinical Research)
Ethical Dilemmas in Genetic Information for Clinical Research
Demystifying Institutional Review Board Structures and Processes
A Regulatory Framework for Testing Artificial Intelligence as a Medical Device
FDA Inspection Readiness: Is Your eSource Fit for Purpose?
2025 U.S. Regulatory Update
The Limits of "De-identification" in Clinical Research Data