Streamlining the Selection and Qualification of Biomarker Laboratories

Biomarkers are crucial tools in the drug development and approval process, but biomarker use presents unique challenges during drug development:

  • New biomarkers are continually being discovered
  • Biomarker trial strategy has become more complex over time
  • Trials using 2 or more biomarkers have risen consistently over time
  • Biomarkers are often associated with additional testing requirements
  • Validation and qualification processes as well as regulations are continually evolving
  • A biomarker lab that focuses on novel assay development for a new biomarker may not meet all the GCLP requirements for evaluating clinical trial samples for the biomarker.

Sponsors need a “fit-for-purpose” approach to qualify each Biomarker Lab for their intended use in support of their drug development strategy.

The Diligent Qualification Platform connects clinical research Sponsors and CROs with biomarker labs and other research service providers, with the aim to dramatically cut the time and resources needed for supplier assessment and qualification.

We offer an effective approach that the clinical research industry can utilize to reduce variability, costs, and cycle times and effectively manage risk in selecting and qualifying biomarker lab providers.

Biomarker laboratory services are the most requested service of all the 21 different service categories and technologies that Diligent offers.

Check out our free Research Report on biomarker lab services for clinical trials!

Immediate access on the next page – no need to wait for approval
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Read our free Research Report on biomarker lab services for clinical trials!

Published in October 2021 and written by our own researchers, our report gives a great insight into the market for trial sponsors, CROs and providers of biomarker laboratory services. It is packed with facts including:

Drug development programs with trials employing patient preselection biomarkers have a 2-fold higher likelihood of approval (15.9%) than those that do not (7.6%).

Clinical trials with biomarkers have risen consistently for at least 10 years

Over half of drug approvals at the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been supported by biomarker data during at least one stage of development (2015 to 2019).

For more details or a free demo of the Diligent Qualification Platform