Due to the potential complexity of clinical trials assay development is a critically important part of the trial design process. With so many variables at play in the process of a clinical trial, ensuring that the design of the trial does not overlook any factors crucial to determining the effect of the treatment is vitally important.
Navigating the requirements of legislation and corporate standards is a difficult task. The primary goal of assay development is to ensure that the best possible data is obtained from a study in a clinical trial setting, meeting all regulatory requirements.
With each clinical trial the device or compound being tested creates unique requirements to accurately predict the product’s effects and control for unexpected variables. Matching the information required from the trial to the taking and analysis of the necessary samples is the core of strategic trial design.
Java Clinical Research’s assays are tailored specifically for the product being trialled. Using standardised assays can lead to compromised clinical trials where unique facets of the product or its use have been overlooked. A rigorous, bespoke trial process will ensure that studies are comprehensive and provide the most accurate results.
This tailored process may incorporate a number of different stages. A number of factors may need to be considered in determining the optimal conditions for identifying drug effects including assay types, samples, timepoints, sample processing procedures, agonists, antagonists and concentrations.
A troubleshooting procedure is also applied to determine any potential shortcomings. If required, on-site sample processing procedures may be streamlined to enable the conduct of the clinical trial. Preclinical testing in ex vivo samples is also carried out where necessary.
Java CR has a strong background in trial management in Europe. By adapting high technology procedures they can provide these specialized procedures on site. This allows for required samples to be obtained through specially developed procedures. Where necessary procedures such as immuno-magnetic separation of blood cells and stimulus-evoked samples from isolated cells can be developed for multiple clinical trial sites.
As part of the assay development process, Java Clinical Research also provides training of site staff in any non-standard sample acquisition, sample processing analysis and shipping procedures to ensure the customised assays are implemented as developed.
To find out more about assay developmentfor clinical trials contact Java Clinical Research on +353 1 6373903 or browse the drug development section of the website.