Assay of PK, PD, BA & BE; clinical evaluation of Biologics
CRS’s trial performance regularly reaches highest ratings in audits and inspections
Overall, clinical trials are strictly regulated to ensure that they follow highest ethical standards and international recognized rules and requirements.
Phase I clinical trials, which follow the preclinical development of a new pharmaceutical compound, represent the first clinical use of the pharmaceutical in humans. In most cases, these First-in-Human (FiH) clinical trials are performed in healthy volunteers. For this, CRS naturally acts on the highest level of care and caution and with long standing experience in the conduct of such clinical trials on all medicinal products – new chemical entity (NCE) just like new biologics.
Our well equipped clinical sites, together with our highly educated and experienced staff guarantee the generation of high quality controlled and validated trial results.
In 2008, 2009, 2010, 2011 and 2014, the U.S. Food and Drug Administration (FDA) performed inspections of bioequivalence studies performed by CRS and awarded the highest rating in all cases: ‘No Action Indicated’.