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.
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: