Integrating multiple clinical processes into a single package is intended to cut costs and improve data consistency and accuracy by streamlining data entry, coding and severe adverse event reconciliation.
"Drug development costs can be significantly reduced by eliminating the overlap and redundant processes that exist across different departments", explained Sylva Collins, vice president of eClinical solutions at Aris.
Streamlining of operations is achieved by focusing “on 'smart integration' across core systems”, added Collins, because this allows “companies to enter data once and share seamlessly across departments”.
The Total Clinical 2.0 package consists of four components, including Aris’ electronic data capture (EDC) system, agCapture, which is scalable to support single site, multi-site and large, international trials.
Aris has also included agXchange IRT (interactive response technology) in the package. This clinical safety system allows users to receive, review and assess safety data from agCapture. Furthermore, agXchange IRT provides an audit trail of data received from the EDC system.
Data is imported from agXchange IRT to ARISg, a pharmacovigilance and clinical safety system. Safety reports can then be distributed to investigators, institutional review boards (IRB) and ethics committees using agXchange SIR.
Aris claims agXchange SIR can deliver a significant return on investment because it eliminates manual and labour intensive printing, sorting and shipping of safety information.
Total Clinical 2.0 is available on a hosted platform, reducing the associated infrastructure and maintenance costs.