Preclinical/Phase I
ICON Development Solutions provides strategy and management in support of non-clinical drug development for all Phases.
Clinical Pathology
ICON’s clinical pathology laboratory is an integral part of our pharmacology services. Co-located in our bioanalytical laboratory in Manchester - local to our hospital-based Clinical Pharmacology Unit - this laboratory provides real-time support for ICON’s Phase I studies, as well as external studies which are being conducted by leading CRO’s in the region
All samples are analyzed on-site in the fully equipped laboratory which focuses on rapid turn-around of results with an emphasis on high quality to provide support for critical safety issues.
Our mainline analysers, which include Roche Integra 400, Beckman Coulter LH750, Sysmex CA1000, Abbott analysers and Clinitek 100 dipstick reader provide a range of accredited and non-accredited analyses.
- Performance is rigorously monitored through internal quality control and external quality assurance schemes
- Fully supported with service contracts for preventative maintenance and repairs
- Linked directly to the ClinAxys II LIMS system providing secure data transfer and management of testing
- LIMS is 21 CFR part 11 compliant - delivering real-time results in password protected pdf result files.
- LIMS Data export is available as ODBC compliant files and Data management services to other formats are available through our Biometrics department to sponsor specification.
The laboratory also routinely provides support for external studies and can provide not only the analysis but also the required resources from kits and requisition form production and distribution through to reporting and data management in a seamless manner.
