Biomarker Laboratories

GCR Laboratories biomarker lab works closely with clients to shape their biomarker strategy and drive projects to completion even where uncertainty exists. Selecting the best analytical technology or method and the best regulatory strategy requires significant discussion and investigation. Our Laboratories takes a collaborative cross-functional approach to each project in order to provide the flexibility needed to develop customised solutions.

Our lab works with clients to:

  • Identify the appropriate biomarker
  • Select the right regulatory approach from fit-for-purpose to full compliance
  • Choose the best analytical methodology
  • Develop and validate the specific assay(s)
  • Confirm intended useful purpose through clinical trials
biomarker lab

Integrated Approach

GCR Labs recognises that biomarkers can be used throughout the entire drug discovery and development continuum. This means there are choices surrounding the biomarker data usage, regulatory compliance, technology and geography.

The biomarker lab is committed to helping clients identify the right strategy for each development phase so that they can efficiently achieve their end goals. To do this, our Laboratories have a dedicated biomarker lab and additional capacity integrated into our bioanalytical lab and our central lab. This integration:

  • Provides flexibility
  • Leverages the experience of GCR Laboratories across bioanalytical and central labs
  • Enables the biomarker lab to apply a tiered regulatory strategy from fit-for-purpose and GCLP to GLP and CLIA
  • Allows the biomarker team to provide a customised development strategy for each project

Our cross-laboratory model of support includes:

  • Working closely with clients to select the right development approach
  • Helping select the best technology platform to meet the unique requirements of each project
  • Developing and validating methods under the appropriate regulatory guidelines at each stage of drug development
  • Transferring and cross-validating assays to different/multiple locations or under multiple regulatory requirements, as needed
  • Providing insight into how to effectively integrate safety and efficacy biomarkers into clinical development
  • Global coverage for studies of all sizes