Management of AEs from clinical trials
Our medical advisors offer expertise in work-flow improvement of safety reporting in clinical trials and well-designed SAE report forms.
PPH plus medical advisor SAE reporting activities span from tracking of the SAE report forms and preparation of comprehensive case narratives to timely provision of completed documents to pharmacovigilance departments. This does include SUSAR processing if so requested. These activities include all concerned communication with the investigative sites, Ethics Committees and authorities as well as an internal QC process.
PPH plus provides a broad range of pharmacovigilance services which is complemented by its Master Services Agreement with spm² – safety projects & more GmbH, based in Hirschberg, Germany.