Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...

GenoSafe advances CLIA pathway for transatlantic ATMP developmentCLIA registration enables GenoSafe to support testing of samples from U.S.-based ...

In the information age, bridging the gap between data and clinical application is crucial. The Center for Clinical and Translational Science (CCTS) is making significant investments in this area. Over ...

Long-Term Survival and Biomarker Analysis Evaluating Neoadjuvant Plus Adjuvant Relatlimab (anti-LAG3) and Nivolumab (anti-PD1) in Patients With Resectable Melanoma Our study included a broad cohort of ...

This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem to ...