Clinical Research Services - Clinical trial study design and data analysis

As a full service CRO, Bionotus offers a wide range of high quality Clinical Research Services. We offer consulting, development and analysis services to companies active in pharmaceuticals, biotechnology, neutraceuticals, medical devices and food industry.

Clinical trial study design

Clinical trials are typically designed for the accurate assessment of the safety, efficacy and / or the mechanism of action of a new drug or device, medical product or procedure. We offer support for support for design of clinical trials, experiments and observational studies tailored to your specific requirements.
Before selecting the most efficient clinical study design, many variables must be taken into account. Distinct types of clinical studies are subject to various types of bias.
Clinical studies are either experimental or observational.

Experimental clinical study design

Patients are assigned to either an experimental or a control group. In drug studies, patients in experimental groups receive the actual drug, while patients in control groups are given a placebo. Patients are unaware of the group they are in. These types of randomized clinical trials (RCTs) offer highest level of experimental validity.

Observational clinical study design

The concept of randomization is not used in observational clinical studies. These types of clinical studies are used to detect correlations between an outcome and a test variable. In most cases however, causality cannot be inferred. Caution needs to be exercised when assuming causality between outcome and test variable.
Observational studies are either analytical or descriptive.
Analytical clinical studies look at the relationship between an outcome and a variable.
In contrast, descriptive clinical studies gather information. Descriptive studies cannot determine causality between a variable and an outcome.

Clinical trial data analysis

See Pharmacometrics Services

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+32-(0)3-443 04 00

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