Bioanalytical services CRO are crucial for reducing costs and better-utilizing   resources during clinical trials. Today it has increasingly become common for large pharmaceutical companies to outsource routine bioanalytics to CROs and focus more on complex internal studies. Bioanalytical laboratories can easily complement the clinical and non-clinical needs of sponsor organizations.

Depending on the size and requirements of a sponsor organization, laboratories provide tailored bioanalytical solutions. Usually, smaller organizations outsource all bioanalytics to CROs. On the other hand, large and mid-size companies often outsource extended bioanalytical research studies. Hence, bioanalytical laboratories have great potential in dictating the fate of clinical trials. Let us further explore the ways a bioanalytical laboratory can influence clinical trials.

What role do bioanalytical services CRO play in the success of clinical trials?

Due to the higher competitive nature of drug development programs, bioanalytical laboratories heavily invest in equipment and technologies that improve performance capabilities. With an increasing demand for drug potency, older instruments often turn obsolete in detecting a wide range of analyte levels in biological samples. Hence, investing in modern cutting-edge technology ensures that bioanalytical laboratories can rapidly provide precise results. 

Along with the latest instruments, bioanalytical laboratories are at the forefront when it comes to using  the latest innovations. Today bioanalytical research is evolving at an exponential rate. Although immunoassay formats such as ELISA are extensively studied and developed, newer approaches such as CD format and Gyrolab workstation are increasingly  employed in bioanalytical research. Moreover, bioanalytical services CRO also use high-resolution LC-MS for protein quantification.  LC-MS systems negate the development of critical reagents required for traditional immunoassays. Lastly, most bioanalytical laboratories have begun moving beyond the use of quantitative PCR to in situ hybridization through branched DNA technology for RNA detection and quantification.

Bioanalytical laboratories have fine-tuned  themselves to consider all aspects of increasing  dose trials on participant safety. CROs employ high-throughput automated liquid handlers for both first-to-file generic drug opportunities and rising dose trials. Such rapid analysis allows researchers to assess up to 2,000 samples a day and reduces timelines associated with drug development programs. Also, as mentioned above, LC-MS is the standard platform for most bioanalysis. However, , bioanalytical laboratories can simply determine whether to use the LC-MS system or to go forward with GC-MS and TOF-MS instruments, through several projects and method developments.

Finally, bioanalytical laboratories are always up-to-date with the ever-evolving drug regulatory environment. Every country has its regulatory requirements for bioanalytical research. Moreover, these requirements are never constant. The success of any bioanalytical research depends on the fulfillment of all standard regulatory guidelines. Hence, by knowing and fulfilling regulatory recommendations in each country and region, bioanalytical laboratories help expedite the completion of clinical and nonclinical trials.

The road ahead for bioanalytical laboratories in clinical trials

Bioanalytical laboratories can reduce costs, accelerate timelines and generate rapid and high-quality results, whether performing early drug discovery studies or critical in-human clinical trials.. Hence, depending on the size of a sourcing organization, bioanalytical services CRO can manage clinical research and help increase the success rates of clinical trials.

By Adam

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