Beyond obvious regulatory requirements, results generated from bioanalytical studies are of utmost importance. Bioanalytical studies provide valuable data on therapeutic doses and associated adverse effects. Bioanalytical scientists use these data to determine half-life, exposure, and other pharmacological parameters, which are necessary to guide researchers about the therapeutic doses without unwanted toxic effects.
However, with increased demand for newer drug products, drug developers are under immense pressure to bring new drugs to the patient population. Hence, outsourcing bioanalytical studies was the apparent transition in the drug discovery and development processes. But what is drug discovery? Drug discovery aims to identify potential drug compounds and employ them against disease and medical conditions. So depending on the project needs, companies can outsource studies early in drug discovery or later in the clinical trial phase.
Today bioanalytical services CRO play a massive role in the drug discovery and development processes. Although companies outsource a large portion of studies to bioanalytical services CROs, sponsors must first focus on analytical method transfer. Sponsors must ensure that once a method is developed and studies are conducted, the CRO must be able to transfer the developed method and data back to the sponsor. Let us now understand the role bioanalytical services CROs play in research.
Role of bioanalytical services CRO in research and development
There are numerous benefits of partnering with contract laboratories. Sometimes, the functional capacity of companies exceeds, and they may need a partner laboratory to conduct the remaining experiments. Besides, many companies lack the expertise or equipment to conduct bioanalytical studies, and a CRO will be able to fulfill the expertise and service.
A partner bioanalytical laboratory is particularly beneficial for smaller companies as they fulfill experimental requirements and also work as a consultant and provide valuable insights into the project. As experienced CROs have developed a number of diverse bioanalytical assays, they have gained an in-depth understanding of bioanalyses and analytical method development. Besides, bioanalytical CROs are frequently audited, due to the ever-evolving regulatory landscape, , which eventually benefits their clients.
Bioanalytical services CROs can help save significant amounts of time and resources for small and mid-size pharmaceutical companies. Companies can quickly move their compounds through the drug development phases without developing systems or writing SOPs needed for regulated bioanalyses. They also save on costs by not investing in expensive instruments and equipment and unnecessary payrolls for additional trained staff, QA team, and management systems.
Larger companies ideally outsource routine bioanalysis so that their in-house team can focus on more complex and research-oriented projects. However, they lose the ability of direct oversight that would have been possible with in-house experiments. Besides, automation is the characteristic feature CROs employ to reduce costs and potential errors. They use systems to reduce manual input and data exchange and thus improve the productivity and quality of study data. Moreover, being exposed to multiple projects, customers, and auditors, bioanalytical services CROs continuously optimize their systems and processes.
