Your medicinal product is already approved and you want to gain more knowledge about your product?
Do you need support in the creation of an observation plan, the calculation of the sample size, the choice of the evaluation methods and observation questions?
We conduct for your product observational studies, cohort studies, case-control studies, registry studies and PASS studies in compliance with ethical and scientific standards.
We take over the efficient planning, competent conduct and in-depth evaluation of your non-interventional study (NIS).
You want to learn more about non-interventional studies (NIS)?
Non-interventional studies (NIS) usually relate to already authorized medicinal products and are normally followed by a so-called observation plan. The observation plan shall determine how many patients are to be observed (sample size), determine in advance which evaluation methods are used and what observation questions will be asked.
A NIS will not intervene in the routine treatment of the patients observed, but the patients are being treated under the usual conditions in their doctor’s office.
NIS have the great advantage that the generated data reflect the actual conditions in everyday practice. In contrast, results that are achieved through clinical trials, are significantly inferior transferable to everyday conditions due to the usual in these studies narrow exclusion criteria. The results of a NIS are influenced by many factors from the everyday practice, such as comorbidities and concomitant use of other drugs or the patient compliance (compliance).
The following types of studies belong to the NIS:
- A post-marketing surveillance (PMS) study has the goal to document and evaluate data of a variety of patients. Read more >
- In a pharmaceutical cohort study the effect of drug exposure on the occurrence of adverse events and illnesses is examined. Read more >
- In a case-control study certain diseases and their possible causes – such as a possible connection with a drug therapy – are examined. Read more >
- For a registry study, practical data are collected in a register about diagnosis and treatment in a defined area of indications from of a large group of patients. Read more >
- In a safety trial after marketing-authorization (PASS), the safety risk of a medicinal product which is a already authorized shall be determined, described or quantified, the already developed safety profile shall be confirmed or the effectiveness of risk management measures shall be measured. Read more >
Our experts will gladly advice you personally. We look forward to your call or your message.