Now generally available, Total Clinical 2.0 integrates data from EDC and clinical safety to help companies improve data consistency and accuracy by eliminating redundancies in data entry, coding and SAE reconciliation. The Total Clinical 2.0 solution integrates four key clinical processes:
Electronic data capture: agCapture™ is a feature-rich, proven EDC system that includes award-winning, integrated decision support functionality. It is based on software from Aris Global and InferMed and is fully scalable to support single site, multiple sites, and large, international trials
Clinical safety gateway: agXchange IRT™ enables companies to securely and efficiently receive, review and assess safety data from agCapture before import into the ARISg™ safety system. The solution validates the data for completeness and accuracy, and provides a complete audit trail of data received from the EDC system.
Clinical adverse event reporting: ARISg™ is the market-leading pharmacovigilance and clinical safety system used by more than 300 companies worldwide. ARISg is also available on its hosted and managed platform, agOnDemand™.
Safety report distribution: agXchange SIR™ automates safety report distribution to investigators, IRBs and ethics committees. The solution delivers a significant return on investment as it eliminates manual and labor-intensive effort required by clinical staff to print, sort and ship the increasing volume of safety information.
"Drug development costs can be significantly reduced by eliminating the overlap and redundant processes that exist across different departments," said Dr. Sylva Collins, Aris Global vice president of e-Clinical solutions. "Our approach is to focus on ‘smart integration’ across core systems and enable companies to enter data once and share seamlessly across departments."