Numerous effective supported clinical studies
ClinStat realized considerable number of successful studies
Superb data management is an important factor in clinical research
Services for any phase of drug development
Planning of studies, accurate reporting and approval process
compiling data in the right way, at the right time
ClinStat offers the complete range of statistical services
ClinStat GmbH 2017
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Institute for clinical
research and statistics
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Health economics and outcomes research (HEOR)
Health economics addresses issues related to limitations in the allocation of health and healthcare resources. Limitations implies, that payers had to make choices among multiple, different interventions to get the best way of available funding. In this context demonstrating value for money is different. Does your drug or device improve clinical outcomes enough to justify the funds spent, compared with alternative uses of the same money?
ClinStats health economics and outcomes research services help you to perform:
• Cost of illness studies
• Budget impact analysis
• Piggy back analysis
• Dossier preparation for Health Technology Assessment (HTA) submissions
• Epidemiological and outcomes research studies
• Systematic reviews and meta-
• Qol instrument development and use
Market Access in the Age of the New German Pharmaceutical Pricing Regime (AMNOG)
New legislation, the so-
After the initial launch of the newly licensed drug, the pharmaceutical company has 12 months during which it can set its own price. After 12 months, it must submit a Dossier of Added Value that needs to demonstrate that its new drug has an enhanced benefit or benefits when compared to the drugs already available on the market. Without proof of added value, the company will not be able to continue charging a price that is higher than the price the insurance companies pay for the drugs already available on the market.
The Dossier of Added Value is assessed by the Joint Federal Committee (in German “Gemeinsame Bundesausschuss (G-
The Joint Federal Committee intends that in due course established drugs will also be subjected to added value referencing.
ClinStat offers pharmaceutical companies the professional expertise and skills in statistical analysis and health economics needed for the successful Dossier of Added Value. This includes the compilation of indirect comparisons and network meta-
Various number of successfully realized studies
Our quality management system contributes to fulfilling the requirements of international and national quality standards and ethical principles.
Compliance with required international standards and convincing results