Winicker Norimed GmbH
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Nuernberg, DE
The Winicker Norimed GmbH is an independent, owner-operated contract research organization with seat in Nuremberg. From strategy planning, managing the field phase up to the analyzing your project and writing the clinical study report or publication, we take ownership of your needs!
We deliver quality services in accordance with the relevant regulations and international guidelines, using either our own or customer-specific standard operating procedures.
In cooperation with hospitals and primary care physicians, we manage phase II-IV clinical trials as well as non-interventional and epidemiological studies with pharmaceuticals and studies with medical devices.
Thanks to our many years of experience in the management and conduct of clinical investigations with medical devices as well as nutritional products with health promoting properties, we are able to provide you with effective and individual solutions.
Another main focus of our work is Market Access and Health Service Research.
Scientific and medical consulting as well as training in the medical indications are essential for your successful planning and conduct of your study.
We offer our consulting services and training based on up-to-date scientific standards for a wide range of medical topics. Out team of medical doctors and experts advices and trains your project team continuously and during all project phases.
We provide you with the following services:
Quality assurance through audits is essential for a compliant conduct of your clinical investigations.
Our independent and experienced team of auditors at Winicker Norimed is specialized in quality assurance in clinical investigations. We conduct audits in accordance with current regulatory requirements at investigation sites on your behalf or at your premises.
Our auditors help you to develop countermeasures for risk mitigation, to optimize work processes and to prepare your project for inspections.
We provide you with the following services:
Our team of experienced medical writers has profound experience in the preparation of clinical study protocols, clinical study reports, submission documents, abstracts, posters, publications and further scientific information materials. Moreover, we generate risk management plans, periodic safety update reports etc. (safety writing). In close cooperation with our specialized departments, we achieve the highest quality of services.
Do not hesitate to contact us, if you have further requests in medical writing.
Our range of medical writing services:
Data Management & Biostatistics – Clinical Trials Phase II – IV
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 to ensure a valid statistical analysis.
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:
We at Winicker Norimed provide you with further measures of quality assurance for your project by performing clinical monitoring.
Apart from our in-house CRAs, 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:
Project Management – Clinical Studies Phase II – IV
After your clinical study design has been finalized, we continue to support your clinical trial with efficient project management.
Our experienced and highly-qualified project managers are very engaged, they supervise your projects with the utmost care.
We provide you with the following services:
Scientific and medical consulting as well as training in the medical indications are essential for your successful planning and conduct of your study.
We offer our consulting services and training based on up-to-date scientific standards for a wide range of medical topics. Out team of medical doctors and experts advices and trains your project team continuously and during all project phases.
We provide you with the following services:
Thorough planning of your clinical trial is essential for a successful and cost-efficient study conduct.
Use our extensive experience to ensure optimal strategy planning of your clinical trial!
Our project managers can support you by reviewing the overall strategy, clinical practice and clinical acceptance of your project as well as its compliance with ethical standards.
We provide you with the following services:
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