Good Clinical Laboratory Practice (GCLP) compliance

In addition to the ISO9001:2015 certification, our laboratory in Frankfurt am Main, Germany, has implemented measures and procedures to apply specific assays in a regulated environment.  Compliance is as described under Good Clinical Laboratory Practice (GCLP), according to the “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples” by the European Medical Agency from 2012.

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This applies to Targeted Assay workflows when required as part of a clinical trial.  These are more likely to follow a specific assay development and validation following a Discovery projects,  but we can consider an assay transfer from a third party laboratory as well.  Such assays are routinely undertaken using a TSQ Triple Quadruple Mass Spectrometer as a Selection Reaction Monitoring (SRM) assay, but Orbitrap instrumentation can be incorporated when assays demand a Parallel Reaction Monitoring (PRM) approach.

The compliance of our operations with the GCLP guideline has been repeatedly assessed and confirmed by an independent company, Qualogy Ltd.