5 Tips for Proactively Managing Risks in Your Clinical Studies

Biomarkers have increasingly become an integral part of the clinical research and diagnostic domains. Biomarkers help researchers understand disease progression and assess how patients respond to treatments. However,  biomarkers in clinical research have increased the demand for identifying reliable and valid biomarkers for drug development and drug products.

Several testing laboratories have begun offering comprehensive biomarker testing and analysis packages considering the growing demand for biomarkers. However,  sponsors must make crucial decisions for selecting an ideal outsourcing partner with demonstrated expertise and resources. Therefore, in today’s article, we provide some prime factors to consider while choosing the best biomarker testing services.

What are the prime factors a sponsor must consider when choosing biomarker discovery services or biomarker testing services?

An ideal biomarker testing service should provide comprehensive support in biomarker assay development, validation, and biomarker analysis. The biomarker service laboratory must be capable of applying its expertise at any point in a sponsor’s biomarker discovery and analytical journey.

Biomarker testing services should be able to aid in developing exploratory and custom biomarker assays. The testing partner should use integrated bioanalytical solutions to develop sensitive and specific biomarker assays for a broad spectrum of relevant biomarkers, including novel and informative biomarkers.

Developing a novel biomarker assay is a time and resource-consuming endeavor. Hence, commercially available assay kits can become a less intense alternative to novel biomarker assays. These kits reduce time and resources and are highly portable with ease of use.

Moreover, biomarker studies require adequately validated bioanalytical methods for generating reliable study results. Hence, testing partners should follow the latest regulatory recommendations and provide extensive consultation services and support for biomarker method validation.. Testing laboratories should develop biomarker assays using fit-to-purpose approaches so that they can provide support at any stage of biomarker development. Additionally, testing laboratories must be GxP compliant, adhere to current regulatory guidelines, perform multiplex assays, and have complete expertise in biomarker validation. If a particular testing partner can meet all necessary criteria, sponsors can have the confidence needed while selecting an outsourcing partner for their clinical and preclinical analysis.

As biomarker analysis is an ever-evolving space, testing services must be equipped with the latest platforms for biomarker testing. Whether the biomarker is in the exploratory or development stage, biomarker testing services should leverage necessary platforms and instruments while testing biomarkers and compounds.

Apart from all requirements, testing services equipped with specialized assessment tools can be an added advantage for biomarker analysis. Instruments such as flow cytometry and genomic analysis are becoming increasingly crucial in biomarker discovery and subsequent analysis. Flow cytometry can simultaneously analyze and measure multiple points of hundreds of cells every minute. Hence, flow cytometry becomes vital for assessing biomarker assays such as antigen-binding assays, intracellular and extracellular markers, and immunophenotyping. On the other hand, genomic analysis of biomarkers gives sponsors a unique cross-sectional perspective of their systems and helps make informed decisions for subsequent biomarker analysis.

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By Anita Gale


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