Comprehensive assays ensure that the resulting clinical trials are effective, efficient and provide results that are robust and clear. Every study involves a long list of possible variants and contributing factors. Making sure a trial or study does not miss out on any factors that might undermine the results of the trial or lead to errors in the data is the core of assay development.
There are other factors that must be considered when developing assays that might lie outside of the key goals of the study itself. Corporate standards are one factor that varies from company to company and from product to product. There may even be instances where multiple companies are working together and two sets of standards have to be taken into consideration.
Governmental regulation and legislation are also a major consideration. Ensuring that clinical trials adhere to all of these requirements is critical. At Java Clinical Research, we understand the importance of ensuring all data of studies meets the required regulatory standards. We partner with academic researchers to implement specialised and cutting-edge techniques, but always ensure the data is obtained to the requisite standards. Consider also that these guidelines and regulations are for the safety and benefit of the end consumer they are ultimately what guarantees the continued success of the product and its manufacturer.
Every new product or pharmaceutical being trialled comes with its own particular set of beneficial and adverse effects that will determine its success. For this reason standardised tests are not always adequate to characterise the product.
Java CR provides services that take into consideration all the unique aspects of the product and apply them to the development process. By scrutinising the particular nuances of the product Java CR prevents the compromised results that may come with standardised trials.
Depending on the product the assay customisation may take place through a number of different stages. Determining the optimal conditions for drug effect identification might be one stage. This may include looking at agonists and antagonists, subject samples, concentrations and time-points.
Java Clinical has been able to adapt many cutting edge procedures in order to be able to provide them onsite. For example, Java has performed customised assay development so that procedures that provide stimulus evoked samples from isolated cells and immuno-magnetically separated blood cells can be carried out at clinical trial sites.