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!
With relevant regulations and international guidelines as the basis, the company has delivered such quality services using either own or customer-specific standard operating procedures.
In cooperation with hospitals and primary care physicians, the company has managed phase II-IV clinical trials as well as non-interventional and epidemiological studies with pharmaceuticals and studies with medical devices.
Winicker Norimed has able to provide avid clients with effective and individual solutions all because of the many years of experience in the management and conduct of clinical investigations with medical devices as well as nutritional products with health promoting properties
Another main focus of their work is Market Access and Health Service Research.
1993 - Founded in Nuremberg as full-service institute (clinical trials and observational studies with pharmaceuticals)
1997 - New service: Audits
1998 - New department: Medical Writing
2008 - New service: trainings and training courses New service: clinical investigations with medical devices Relocation of our office to larger premises
2011 - New department: Pharmacovigilance
2012 - New business area: AMNOG / Market Access, opening an office in Munich
2016 - Expanding our office premises in Nuremberg 2017 Opening an office in Berlin
- Clinical Strategy Planning
- Medical Writing
- Medical Consulting
- Safety & Vigilance
- Data Management & Biostatistics
- Quality Assurance & Audits
- Health Services Research
- Benefit Assessment
Pharmacovigilance – Clinical Trials Phase II – IV
The regulatory requirements for the systematic safety surveillanc of your pharmaceutical product are extensive and require profound know how.
Our interdisciplinary team of experts combines experience with continuous training in the current regulatory requirements. We support you with the monitoring of your pharmaceutical product in compliance with all safety requirements.
They provide you with the following services:
- Screening of data from clinical trials for safety relevant aspects
- Preparation and Processing of Individual Case Safety Reports (ICSR), including Follow-up
- Medical Reviews
- Entry of safety data into the sponsors’ databases
- Electronic reporting of case reports to the relevant authorities
- Translation of case-specific documents English-German / German-English (e.g. hospital letters, doctor’s letters)
- Preparation of the Perodic Safety Update Report (PSUR), the Development Safety Update Reports (DSUR), monthly Safety Reports, the Risk Management Plan (RMP)
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|August 14, 2018
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