Clinical specialty testing laboratories, like Champions Oncology, are expected to adhere to stringent standards to ensure accuracy and reliability of test results which can have life-altering implications for patients. Regulatory compliance is not a mere bureaucratic hoop but a foundational element that guarantees the integrity of laboratory operations. Navigating through the complex landscape of clinical specialty testing and its regulatory environment is crucial for the success of each clinical trial. Regulatory compliance within each clinical trial is vital to ensure data validity and also ensures each laboratory’s commitment to patients’ safety. In this blog post, we’ll explore the intricacies of adhering to Good Clinical Laboratory Practice (GCLP), Clinical Laboratory Improvement Amendments (CLIA), and College of American Pathologists (CAP) standards, compare regulatory frameworks in the United States (US) versus the European Union (EU) and underscore why meticulous regulatory compliance is a non-negotiable for each clinical trial.
