Our biomarker services team has extensive experience and expertise in supporting clinical studies for the world’s leading pharmaceutical companies and we typically support in excess of 200 clinical trials at any given time. Tepnel has been audited multiple times by the MHRA and our GCP compliant service is fully bespoke to fit your needs.
Biomarker discovery and verification
The identification of biomarkers can be carried out using a wide range of platforms including our own proprietary chemistries. These studies can utilise samples from a wide range of sources including pre-clinical or clinical studies. Our team will support you through every aspect of your biomarker discovery and verification project, from initial study design through to data analysis.
Assay development and validation
The development of an assay for use in a clinical trial is a three stage process underpinned by an initial assay development stage to ensure that the assay is fit for transition into a clinical setting. Following assay development an analytical validation study is carried out prior to the assay being used for the processing of clinical samples.
Tepnel has significant experience in both assay development and validation, your Project Manager will work with you to ensure that your assay and study design is fit for transition into a clinical setting.
Regulatory compliant processing of samples from clinical studies
Samples that are run as part of a clinical trial cannot be handled using standard “Research Use Only” processing. Tepnel has decades of experience in the validation and processing of assays to GCP standards and our quality system has been audited by the MHRA since the 1990s.