Product development, risk research with volunteers

When producing a new product (Pharmaceutical, Functional Food, etc.) you want to measure the impact of any exposure (pharmaceutical, food, environmental risk) on humans.

Typically this is not done via a clinical trial. The questions may be better answered if you test a small volunteer cohort under well controlled conditions. The detailed study design depends on the product (risk) and the specific question.

We assist our clients to plan the right size and endpoints. Endpoints (parameters, study variables) can be obtained via a structured interview, questionnaire for self reporting, a psychological test, a laboratory investigation (blood analysis),etc.

The dose-effect relationship can be measured in a smaller cohorts more economically than in field trials.

It is more exact to test cholesterol levels or blood sugar concentrations in a small cohort under controlled conditions than in larger field studies.

Only if the product is already on the market it may be an option to work with a larger number of volunteers. Then the specific question is not only about dose-response relationship, but also on customer and patients compliance. There are other issues, which can be tested only in larger clinical trials.