Clinical Trial Support
Everybody deserves to be treated differently
Who should monitor the active dose?
We offer our patented method of analyses to companies in clinical trials, who are developing new products, exploring new indications or defining interesting patient groups. If your company wants better statistical data, has substances with narrow therapeutic windows or struggles with toxicity contact us to discuss possible solutions.
Phase I Clinical trials
In early stage clinical trials, we can help determine the approved dosing. By monitoring the active dose in phase I studies the Maximum Tolerable Dose can be viewed with regard to the actual effect in the individual and an early stage inter individual dose can be established.
Phase II & III Clinical trials
In later stages monitoring the active dose will provide a better understanding of the variations in tox response. Monitoring could also provide a direct correlation between dose, effect and different patient groups. Factors such as age, genetics, sex and lifestyle can all provide possible variations in metabolism and determine subgroups with different dose demands.
We can also give a better understanding of how the effect is correlated to the active dose, and thus a stronger statistical support for your studies when outliers can be accounted for.
In general, monitoring the dose gives a better chance of avoiding undesirable side effects and clearly singles out the patients where the metabolite is present at a level below the presumed threshold for desired effects.
What can we offer?
We develop tailor made methods with a high sensitivity for all reactive substances that binds covalently to biomarkers. With the help of TailorDose we can monitor how the active dose varies on an individual level. Depending on the substance we need one or two samples per patient taken at a flexible interval after infusion. No further sample preparation is needed and our lab provides fast and easy analyses.
Our ongoing clinical trials