Because quality is your revenue and reputation
Resources
There is an abundance of information available on the internet regarding clinical research and development, regulatory compliance and quality management.
Some of it, like that found on the FDA or EMA websites, is very reliable but may not always be easy to locate. Other information you find during an online search may not be relevant to your specific question or needs.
As part of our commitment to educate, on this page you will find links to reliable resources that have been vetted by QRCP Solutions, Inc. and may help you with your regulatory compliance and quality management activities.
As always, please feel free to contact us directly for assistance.
US Food and Drug Administration (FDA)
Clinical Trials and Human Subject Protection main page
Clinical Trials Guidance Documents
Medical device development Case Studies and other education material
The Biomarker Qualification Program and educational materials on biomarkers
Replies to Inquiries to the FDA on GCP Topics
European Medicines Agency (EMA)
Human research and development main page
Guideline on Bioanalytical Method Validation
Good Clinical Laboratory Practices
ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)
ICH E6(R2) - Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice
Other Helpful Information
FDA's CDRH Learn portal, including case studies
FDA's CDER Small Business Assistance Learn portal for pharmaceutical industry