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Nutritional Supplements

Nutritional Supplements

 

Nutritional products with health promoting properties

Our expert team at Winicker Norimed GmbH mangages and conducts studies with nutritional products with health-promoting properties such as, for instance, dietary supplements, “functional food” or dietetic foods. We plan your study adjusted to your specific needs and in accordance with the European Health Claims Regulation (HCVO) as well as relevant national regulations and international standards.

Our qualified team has profound expertise regarding studies with nutritional products with health-promoting properties in accordance with GCP guidlines. We guarantee a high ethical and scientific standard of your project with nutritional products. Use our extensive experience to demonstrate your “claims” scientifically.

Through a flexible project design, a thorough planning phase and customer oriented solutions we match our services to your needs and requirements.

Our services for Nutritional Supplements:

Clinical Strategy Planning

Clinical Strategy Planning

Thorough planning of your study with nutritional products with health promoting properties is essential for a successfully and cost-efficient study conduct.
Use our extensive experience to ensure optimal strategy planning of your projects.

Our project managers can support you by reviewing the overall strategy and clinical acceptance of your project as well as its compliance with ethical standards.

We provide you with the following services:

  • Distinction between dietary supplements and pharmaceutical products
  • Consultation on study design, including the evaluation of your project regarding its feasibility and the current national and international regulations.
  • Conduct of feasibility studies
  • The preparation of an overall design for your projects in accordance with the relevant national and international regulations as well as with the relevant literature.
  • Preparation of study specific documents, including the clinical investigation plan, patient information, informed consent and the case report forms (electronic and/or paper-based)
  • Planning of quality assurance measures (monitoring, audits)

Submissions

Submissions

As clinical investigations with nutritional products with health promoting properties are categorized as “free or other research projects”, it is obligatory for physicians that participate in such a clinical investigation to receive consultation by an ethical committee according to §15 BO (German professional code for physicians)

Registration of your study with the ethical committees.

We provide you with the following services:

  • Preparation of the documents relevant for submissions to ethics committees
  • Obtaining essential documents from the investigational sites
  • Submission (and deregistration) of clinical investigations with health-promoting properties ethical committees
  • Consulting on and preparation of interim reports (including Safety Reports) for EC submissions

Project Management

Project Management

After careful planning of your study with nutritional supplements, “functional food” or dietetic supplements and its submission to ethics committees, we continue to support you in the area of project management.

To ensure a reliable and valid data collection, our project managers and experts for nutritional products with health promoting properties supervise your projects with the utmost care.

We provide you with the following services:

  • Project controlling, including budget and milestone management
  • Contract management
  • Study-specific training of all parties involved
  • Maintenance of the Trial Master File
  • Organization and conduct of investigator meetings
  • Coordinating point of contact for the investigation sites and their team
  • Communication with the relevant ethics committees

Monitoring

Monitoring

We provide you with further measures of quality assurance for your project by performing clinical monitoring.

Apart from our in-house monitors, we have a large number of qualified freelancer CRAs at our disposal. This allows us to operate highly cost-oriented and flexible.

We provide you with the following services:

  • Identification and selection of investigational sites
  • Implementation of: Qualification visits, initiation visits, monitoring visits (remote and on-site, on a risk-based) for Source Data Verification, Close-out visits
  • Training of the investigational sites for individual studies, tailored to the specific regulatory requirements of studies with nutritional products with health promoting properties
  • Screening for and management of protocol deviations
  • Site management
  • Supporting investigational sites with safety reporting

Data Management & Biostatistics

Data Management & Biostatistics

Our team at Winicker Norimed has many years of experience in data management and biostatistics. Our data managers, coders and biometricians will take ownership of your needs and make sure that the evaluation of your clinical data is consistent and accurate.

Our experts will positively engage in your project. We will work closely together with you to make sure that the focus of our work is directed towards achieving your project-specific goals.

We provide you with the following services:

  • Statistical consulting
  • Statistical analysis plan
  • Database development in accordance with CDISC standard
  • Electronic and paper-based CRF design
  • Data entry, validation and data cleaning (including Audit Trail)
  • Event coding (according to standard codebooks, MedDRA and WHO-DD)
  • Statistical analysis (on the basis of SAS)
  • Interim analysis

Clinical Strategy Planning

Clinical Strategy Planning

Thorough planning of your study with nutritional products with health promoting properties is essential for a successfully and cost-efficient study conduct.
Use our extensive experience to ensure optimal strategy planning of your projects.

Our project managers can support you by reviewing the overall strategy and clinical acceptance of your project as well as its compliance with ethical standards.

We provide you with the following services:

  • Distinction between dietary supplements and pharmaceutical products
  • Consultation on study design, including the evaluation of your project regarding its feasibility and the current national and international regulations.
  • Conduct of feasibility studies
  • The preparation of an overall design for your projects in accordance with the relevant national and international regulations as well as with the relevant literature.
  • Preparation of study specific documents, including the clinical investigation plan, patient information, informed consent and the case report forms (electronic and/or paper-based)
  • Planning of quality assurance measures (monitoring, audits)

Submissions

Submissions

As clinical investigations with nutritional products with health promoting properties are categorized as “free or other research projects”, it is obligatory for physicians that participate in such a clinical investigation to receive consultation by an ethical committee according to §15 BO (German professional code for physicians)

Registration of your study with the ethical committees.

We provide you with the following services:

  • Preparation of the documents relevant for submissions to ethics committees
  • Obtaining essential documents from the investigational sites
  • Submission (and deregistration) of clinical investigations with health-promoting properties ethical committees
  • Consulting on and preparation of interim reports (including Safety Reports) for EC submissions

Project Management

Project Management

After careful planning of your study with nutritional supplements, “functional food” or dietetic supplements and its submission to ethics committees, we continue to support you in the area of project management.

To ensure a reliable and valid data collection, our project managers and experts for nutritional products with health promoting properties supervise your projects with the utmost care.

We provide you with the following services:

  • Project controlling, including budget and milestone management
  • Contract management
  • Study-specific training of all parties involved
  • Maintenance of the Trial Master File
  • Organization and conduct of investigator meetings
  • Coordinating point of contact for the investigation sites and their team
  • Communication with the relevant ethics committees

Monitoring

Monitoring

We provide you with further measures of quality assurance for your project by performing clinical monitoring.

Apart from our in-house monitors, we have a large number of qualified freelancer CRAs at our disposal. This allows us to operate highly cost-oriented and flexible.

We provide you with the following services:

  • Identification and selection of investigational sites
  • Implementation of: Qualification visits, initiation visits, monitoring visits (remote and on-site, on a risk-based) for Source Data Verification, Close-out visits
  • Training of the investigational sites for individual studies, tailored to the specific regulatory requirements of studies with nutritional products with health promoting properties
  • Screening for and management of protocol deviations
  • Site management
  • Supporting investigational sites with safety reporting

Data Management & Biostatistics

Data Management & Biostatistics

Our team at Winicker Norimed has many years of experience in data management and biostatistics. Our data managers, coders and biometricians will take ownership of your needs and make sure that the evaluation of your clinical data is consistent and accurate.

Our experts will positively engage in your project. We will work closely together with you to make sure that the focus of our work is directed towards achieving your project-specific goals.

We provide you with the following services:

  • Statistical consulting
  • Statistical analysis plan
  • Database development in accordance with CDISC standard
  • Electronic and paper-based CRF design
  • Data entry, validation and data cleaning (including Audit Trail)
  • Event coding (according to standard codebooks, MedDRA and WHO-DD)
  • Statistical analysis (on the basis of SAS)
  • Interim analysis

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