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agConnect™
Efficient reconciliation of data between safety systems and the clinical systems
Across multiple studies, clinical safety data managers are faced with the challenge of reconciling the 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 are seeking a solution that can ensure the quality of study data prior to analysis of safety and efficacy.
agConnect is a solution designed to facilitate the reconciliation and transfer of safety data between clinical data management systems and ARISg. agConnect provides printed summaries and detailed reconciliation reports by patient and study for quick determination of any discrepancies in the data.
As with all Aris Global products, agConnect is available as a hosted solution on the agOnDemand platform. For more than four years, agOnDemand has been providing best-in-class, cloud-based
services to life science companies to help them meet their regulatory requirements without the pressure of maintaining sophisticated IT infrastructures.
Full ARISg safety data reconciliation
agConnect integrates seamlessly with ARISg and can integrate with other CDM systems through automatic transfers from the EDC or CDM database to the ARISg system. Other key features of agConnect are:
- Automates discrepancy and action item notification
- Flexible data mapping capability allows CDM/CRO file data elements to be mapped to a set of SAE reconciliation fields supported against ARISg
- Support for data received from CROs can be in CDISC SDTM format or E2B format
- Reconciliation support provided at patient and/or case level
- Creates detailed data reconciliation reports
Accelerated study closeout and database lock
Continuous data reconciliation against the safety system throughout the duration of the clinical trial ensures the quality of the 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. Other benefits include:
- Ensures compliance and consistent safety data reporting
- Provides significant efficiency in the safety data reconciliation process
- Ensures quality of safety data prior to clinical data analysis
- Enables accelerated clinical study close-out and data lock
- Automates manual processes and increases reconciliation efficiencies
- Enables more accurate drug safety profiling
- Eliminates redundant data entry from EDC to safety systems
Contact us
Email: info@arisglobal.com
Phone: Worldwide Locations
