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Central Laboratories

Ask an Expert: Understanding Regulation and Validation Processes for Biomarkers

  • April 28, 2020
We sat down with Christopher Daniels, Director, Clinical Laboratory Services at Medpace, to discuss regulations and standards for biomarkers, validation process for central labs, and the benefit of working with an experienced partner. Below is a sample of the article. For the full interview click here.

What regulations and guidelines do Medpace’s central laboratories follow?

Medpace follows Good Clinical Practice (GCP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. For standards, we follow Good Clinical Laboratory Practice (GCLP) and College of American Pathologists (CAP).

What are the GCLP guidelines?

GCLP is a combination of GCP and Good Laboratory Practice (GLP) regulations from the generic best practice (GxP) guidelines created by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). In 2003, the Research Quality Association (RQA) suggested a new guideline. Later the World Health Organization (WHO) and the British Medicines and Healthcare Products Regulatory Agency issued their versions of a GCLP guideline. For central labs, we use the WHO guidance.

What is a validation plan, and why is it important?

The validation plan defines the experiments that we’re going to complete for the analytical method and states
the expected acceptance criteria, which will tell us if the validation was successful.

Do you have some idea of what you need to see to consider it a successful experiment?

Yes, each experiment will have criteria set that it must pass, or the bare minimum for it to be acceptable. Those criteria may include: precision, accuracy, analytical measuring range, sensitivity, reference range, interfering substances, and stability.

What’s the importance of having a team of PhD scientists?

The PhD scientists are integral to Medpace’s scientific consulting service. Early engagement with the Sponsor and their scientists goes a long way if we’re involved early on because Medpace knows how to manage biomarkers within clinical trials. Our PhDs are experts at testing biomarkers for clinical studies. Our scientists will guide Sponsors who may only have a GLP (pre-clinical) background to understand the
requirements for clinical work.

Read the Full Interview Here