Numerous effective supported clinical studies

ClinStat realized considerable number of successful studies

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ClinStat - Data Management

Data Management

Superb data management is an important factor in clinical research

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ClinStat - Statistical Programming

Stat. Programming

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Services for any phase of drug development

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ClinStat - Medical Writing

Medical Writing

Planning of studies, accurate reporting and approval process

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Clinstat - HEOR/Market Access

HEOR/Market Access

compiling data in the right way, at the right time

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Biostatistics

ClinStat offers the complete range of statistical services

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ClinStat - Statistical Programming

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ClinStat GmbH

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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

       Cost-effectiveness modeling

       Piggy back analysis

       Dossier preparation for Health Technology Assessment (HTA) submissions

       Epidemiological and outcomes research studies

       Systematic reviews and meta-analysis

       Large-database analysis

       Qol instrument development and use


Market Access in the Age of the New German Pharmaceutical Pricing Regime (AMNOG)

New legislation, the so-called “Arzneimittelmarkt-Neuordnungsgesetz” (which may be translated as the  Act for the New Regulation of the Pharmaceutical Drugs Market) was introduced in Germany in January 2011. It obliges pharmaceutical companies to demonstrate that their newly licensed drug provides added value when compared to drugs already available on the market.

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-BA)) and the Institute for Quality and Cost Effectiveness in the Health Service (in German “ Institut für Qualität und Wirtschaftlichkeit in Gesundheitswesen” (IQWiG)) by reference to a comparator also specified by the Joint Federal Committee.

Scores 1-4 denote an added therapeutic benefit category, score 1 being a major benefit, which allows the drug company to negotiate a price with the National Association of Health Insurances that is in excess of the price of an already available drug. Scores 5 and 6 denote no added benefit or a benefit inferior against the selected benefit category, meaning that the new drug will be subject to price referencing. That is, its price will be determined in reference to the already available drugs in comparison to which it has failed to establish an added benefit or added value.

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-analyses.

HEOR / Market Access

Market Access

Various number of successfully realized studies

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Clinical Studies

Our quality management system contributes to fulfilling the requirements of international and national quality standards and ethical principles.

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Quality Management

Compliance with required international standards and convincing results

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Biostatistics

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business solutions

Data Management
Biostatistics
Statistical Programming
HEOR/Market Access
Medical Writing