CRS ACADEMY PROGRAM

Our Academy Program offers training and workshops on a variety of topics for life science and clinical research companies. We customize presentations to the needs of our clients.

Here’s what we can train your teams on…

• Understanding risks in your business
• Quality by design
• Inspection-readiness
• Human-centered design in clinical operations
• The elements of informed consent
• Risk-based Monitoring (RBM) and Risk-benefit assessments
• EHR-to-EDC Interoperability
• 21 CFR Part 11 Update 2017
• 21st Century Cures Act
• HITECH, ARRA: American Recovery and Reinvestment Act of 2009
• HIPAA and Privacy Laws
• GDPR
• PhRMA, EUCOMED and ADVAMED Code of Ethics
• Emergency Research 21 CFR 50.24
• Emergency Use of a Non-Approved Device
• Exempt Research
• ISO14155
• EU MDR
• You get the idea.