Clinical Trials

GCP certification since 2015

By validating assays upon human tissues whilst your drugs are at a preclinical stage, we can be ready to support your Phase 0 to Phase 2 Clinical Trials when we receive the first patient study samples. We can source the appropriate tissues and carry out IHC assay reproducibility studies to ensure reliability.

Histologix can undertake screening of patient biopsies using IHC & ISH methods, pre and post therapy, to identify the effects of your drugs upon healthy human subjects or those within a specific therapeutic cohort. Using the appropriate image analysis algorithms, data can be generated to give an indication of treatment effectiveness.

Patient recruitment and Study Design

Histologix can use IHC and ISH to characterise protein and mRNA expression from patient biopsies, this information can be used to identify patients for inclusion or exclusion as required by the study design, eg. Triple negative patients with breast carcinoma or HPV16/18 presence.

The Design of your study is of utmost importance, Histologix offers a wide range of solutions and controls to ensure patient tissues and subsequent biomarker evaluation of each clinical trial is deigned and standardised in the most appropriate way. Standardisation is critical when comparing quantified endpoint data, whether that is via digital image analysis or Pathologist report.

Tissue Handling Protocols

Tissue collection, shipping and processing SOPs can be provided to investigational sites. Site training and Biopsy Kits can be constructed where required.

GCP Clinical Trial Support

Patient Stratification

Study Design for Tissues

Digital Image Analysis Endpoints

Pathologist Report