Post-Authorisation Safety Studies and their challenges
In the 2021 May issue of the renowned magazine International Clinical Trials, SSS reported about its experience in and knowledge of Phase IV trials. In this article, our authors focused on Post-Authorisation Safety Studies and their specific challenges when guiding and supporting sites in obtaining high quality data and in keeping timelines. SSS gained experience in this field from several studies and just recently implemented an IT solution for communication logs of the medical scientific expert team of the sponsor. By this means, SSS has facilitated the joint support from both, the CRO and the sponsor.
Proprietary CTMS System accSIS helps SSS to stand global challenges
The increasing regulatory demands and the globalization of research has made clinical projects more and more demanding in recent years. In nowadays CROs have to handle much more information and interfaces. Starting already 15 years back SSS has developed a company-own Clinical Trial Management System (CTMS) system. Grown to a powerful tool it meets all requirements off full-service clinical projects in a global setting. SSS currently performs projects in 22 countries on three continents. In a recent publication in European Pharmaceutical Contractor from August 2020 we describe how such an integrated system enables mid- size CROs to perform even huge global projects.
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