agConnect™

safety data reconciliation & transfer

Across multiple studies, clinical safety data managers are faced with the challenge of reconciling safety data between the safety system and the clinical system prior to study closeout and database lock. With the need for consistency in reporting to regulatory authorities, companies seek a solution that can ensure the quality of study data prior to analysis for safety and efficacy.

Full ARISg safety data reconciliation

agConnect is the Aris Global^® solution that enables organizations to automate and ensure the compliance of consistent safety data reporting from safety and data management. agConnect supports ARISg safety data reconciliation directly against the clinical data management (CDM) database or with data files provided by a CRO, automating discrepancy and action item notification to clinical and safety data managers.

agConnect integrates seamlessly with ARISg and can integrate with different CDM systems through automated transfers from the EDC or CDM database to the ARISg system.

Accelerated study closeout and database lock

Continual safety data reconciliation against the safety system throughout the duration of the clinical trial ensures the quality of safety data prior to analysis, helping to accelerate study closeout and database lock. Where multiple studies are involved, agConnect offers significant efficiency gains by automating the safety data reconciliation processes.