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Market Access

Market Access

 

We offer consulting services based on up-to-date scientific standards for a wide range of medical topics. We advise you on how to demonstrate the benefits of your pharmaceuticals after they have received their marketing authorization, especially regarding the legal requirements in connection with the benefit assessment of new drugs that are entering the German market.

 

We support you effectively with our interdisciplinary expertise concerning the entry of your product to the market. This includes the strategic preparation for the market access as well as planning and writing of complete benefit assessment dossiers in accordance with § 35a SGB V.

 

Our highly-qualified team has long-standing cooperations and many working years of experience in the pharmaceutical industry. We advice you on a wide range of specialized topics that may arise in the course of a pharmaceutical’s life cycle. Handling these individual steps properly is essential for successfully marketing your product.

 

We counsel you on possible study designs regarding various topics in health services research (including the use of existing data sources within the health care system).

 

Moreover, you can rely on our professional expertise regarding the scientifically correct estimation of key epidemiologic characteristics (e.g., incidences, prevalences), absolute patient numbers and calculation of healthcare costs.

 

Depending on your needs, the outcome of our consulting services can result in the preparation of documents suitable for internal strategic decision making or the communication with external stakeholders.

 

Our consulting services may lead to the management of clinical trials or specific non-interventional studies or to other services which Winicker Norimed has been offering for many years successfully. You will profit from Winicker Norimed’s structure, as we can offer you a combination of services without the need to switch the provider at the end of a consulting project (see Services).

 

Our Services at Market Access

Benefit Assessment

Benefit Assessment

 

  • Strategic consulting for market access regarding benefit assessment procedures
  • Consultation associated with Advisory Boards
  • Preparation and support of GBA-consultations
  • Preparation of benefit assessment dossiers (§35a SGB V and GBA code of conduct, respectively): single modules or complete dossiers
  • Strategic consulting during the development process to establish an evidence base
  • Methodological advice
  • Systematic reviews, meta-analyses, indirect comparisons
  • Study concepts to prove benefit / additional benefit
  • Budget impact analyses, cost analyses

 

Health Services Research

Health Services Research

 

  • Development of study concepts for many aspects of health services research: conduct, analysis, interpretation of results in context
  • Planning and conducting of prospective studies (‘pragmatic trials’) and retrospective study designs
  • Analyses of secondary data (analyses based on routine data across all healthcare sectors)
  • Analyses of the quality of care in the healthcare system

 

Epidemiology

Epidemiology

 

  • Search for appropriate information resources or databases to extract key epidemiological characteristics; analysis and processing of the information
  • Identification of appropriate disease or product registries
  • Development of study concepts, planning and conduct of analyses based on data from existing registries
  • Conceptual design and set-up of new disease or product registries
  • Conduct of prospective register studies
  • Pharmacoepidemiological studies (concept, conduct, analysis, interpretation)

 

Benefit Assessment

Benefit Assessment

 

  • Strategic consulting for market access regarding benefit assessment procedures
  • Consultation associated with Advisory Boards
  • Preparation and support of GBA-consultations
  • Preparation of benefit assessment dossiers (§35a SGB V and GBA code of conduct, respectively): single modules or complete dossiers
  • Strategic consulting during the development process to establish an evidence base
  • Methodological advice
  • Systematic reviews, meta-analyses, indirect comparisons
  • Study concepts to prove benefit / additional benefit
  • Budget impact analyses, cost analyses

 

Health Services Research

Health Services Research

 

  • Development of study concepts for many aspects of health services research: conduct, analysis, interpretation of results in context
  • Planning and conducting of prospective studies (‘pragmatic trials’) and retrospective study designs
  • Analyses of secondary data (analyses based on routine data across all healthcare sectors)
  • Analyses of the quality of care in the healthcare system

 

Epidemiology

Epidemiology

 

  • Search for appropriate information resources or databases to extract key epidemiological characteristics; analysis and processing of the information
  • Identification of appropriate disease or product registries
  • Development of study concepts, planning and conduct of analyses based on data from existing registries
  • Conceptual design and set-up of new disease or product registries
  • Conduct of prospective register studies
  • Pharmacoepidemiological studies (concept, conduct, analysis, interpretation)

 

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