Quality
Our quality management system meets the highest standards concerning the quality and integrity of all data we produce and ensures due diligence with regard to sample management, data generation and analysis, documentation and archiving and clinical trial subject rights.
Quality
Our quality management system meets the highest standards concerning the quality and integrity of all data we produce and ensures due diligence with regard to sample management, data generation and analysis, documentation and archiving and clinical trial subject rights.
Good Laboratory Practice (GLP)
The Immune Analytics laboratory is certified to work in compliance with the principles of Good Laboratory Practice (GLP). Certification covers immune monitoring and immune kinetics with focus on EliSpot / FluoroSpot analyses.
Compliance with GLP guidelines is ensured by rigorous QA monitoring of GLP studies, processes and facilities as well as recurrent authority inspections.
Good Clinical Laboratory Practice (GCLP)
All processes executed in the Immune Analytics laboratory are fully compliant with the international guidelines for Good Laboratory Clinical Practice (GCLP).
Thus, we ensure that your clinical trial data is recognized by regulatory agencies worldwide.
GCLP standards are continuously monitored by QA as well as sponsor audits.
Development & Validation
We develop and validate customized assays based on our established EliSpot / FluoroSpot platform in order to offer the best analytics for your (pre-) clinical samples.
Our experienced scientists provide robust assay development followed by extensive validation according to recognized international standards to ensure reliable and reproducible data generation.
Project & Study Management
We provide the optimal mix of expertise and efficacy needed to deliver high quality project and study management for your bioanalytical projects.
Our skilled colleagues in project management and study management (study director) have repeatedly proven their strength in the biotech and bioanalytical space. They bring in hands-on experience from working in bioanalytical laboratories and drug development projects, ensuring that a remarkable track record of scientific expertise enriches your projects along the way.
