Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key...more
5/28/2025
/ Audits ,
Best Practices ,
Clinical Trials ,
Compliance ,
Data Integrity ,
Data Management ,
Good Clinical Practices ,
Health Canada ,
Inspections ,
Regulatory Agencies ,
Risk Management ,
Standard Operating Procedures
A recent False Claims Act (FCA) litigation—Jensen ex rel. United States of America v. Genesis Laboratory—highlights critical compliance risks for laboratories. This case reinforces the need for laboratories to ensure...more
Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more