Medical writing at Winicker Norimed
Maximum quality by cooperation among specialist departments
Our team of experienced medical writers has profound experience in the preparation of scientific information material. Through close cooperation among our specialist departments, we achieve the highest quality of services.
In addition to meticulous planning and management, accurately written study protocols or observational plans and coherent study reports are vital for successful study conduct and project completion.
For clinical and non-interventional studies as well as CTD modules, the ICH guidelines (e.g. ICH-E3, ICH-E6 and ICH-M4) and, where applicable, the PASS recommendations by the EMA, are the foundation of our work. In the medical devices sector, we also work in accordance with ISO14155 and MEDDEV.
Our range of services
in medical writing
- Clinical study protocols and observational plans
- Interim and final reports for clinical studies
- Post-Authorization Safety Studies
- Creation of CTD modules within the context of authorization procedures (in particular clinical overview and clinical efficacy or safety summaries)
- Safety writing (PSUR/PBRER, RMP)
- Abstracts and posters
- Publication manuscripts
Your contact
for medical writing
Dr.
Christina Windisch
Head of Medical Writing
christina.windisch@winicker-norimed.com
+49 (0) 911 / 92680 – 8736
Winicker Norimed GmbH
Deutschherrnstraße 15-19, 90429 Nuremberg
Phone: +49 (0) 911 / 9 26 80 – 0
Fax: +49 (0) 911 / 9 26 80 – 8839
E-Mail: wn@winicker-norimed.com