e-SAFETYM - electronic Safety Management

    The e-SAFETYM functionality enables the detailed collection of serious and non-serious adverse event data in addition to the management of pharmacovigilance related activities.

For any new or updated serious adverse event, an automatic email notification can be sent to authorised safety personnel thereby guaranteeing the reporting of SAEs within required timelines.

This functionality also enables the generation and resolution of SAE related e-DCFs with email notifications being sent to the responsible site personnel when prompt resolution is required. The generation of customisable reports in industry standard formats (e.g. CIOMS, E2B, patient narratives) combines patient data from e-CRFs with information completed in e-SAFETYM.

Workflow between clinical sites and safety management teams is streamlined, resulting in significant time and resource savings.

Key features and benefits of e-SAFETYM are: Easily configurable to meet each study’s requirements Automated email notification of SAEs to authorised safety personnel Prompt resolution of queries and follow-up of reported events Timely creation of patient reports (e.g. CIOMS, E2B format) and SAE narratives Reconciliation unnecessary as SAEs are only reported once in the application Increased efficiency for the management of SAEs CDISC compliant

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