“Clients tell us that the response time of sites is improved 100%”, said Susan Lewenz, VP of AxxiTRIALS. “Moreover, significant staff time is saved and ROI/profitability improved as the AxxiTRIALS automated engine can do much of the work heavy-lifting that was previously done manually.”
AxxiTRIALS captures read-confirmation and/or 21 CFR Part 11-compliant eSignatures and any associated metadata, and stores the responses in the site e-Binder, all without the human error introduced by older, manual processes. The system also automatically does the “chasing”, reminding sites when they have not responded within the required time frame, and provides past alerts to trial newcomers.
Staff user dashboards and tracking tools help determine when human intervention is required. Automatically updated real-time interactive management dashboards and reports support management oversight of process and people and provide transparency. The full audit trail is automatically captured throughout the process to prove regulatory compliance.
About AxxiTRIALS
AxxiTRIALS speeds clinical trial operations from Feasibility to Close-out allowing studies to complete on time and on budget with the required quality of data. As a secure mobile portal, AxxiTRIALS reduces trial start-up and operations management time throughout an entire project by automating tasks such as reports, alerts and archiving processes. AxxiTRIALS reduces time spent at clinical research sites by PIs and study site coordinators by simplifying their technology experience with a single solution for all trial content and systems. With leaderboards, community tools, and live access to CRO staff, AxxiTRIALS increases site engagement for internal staff. AxxiTRIALS is the only portal to deliver real-time reporting of all KPIs, including a snapshot view of all leading and lagging indicators for full transparency into the status of sponsored trials.
Media Contact:
Tom Teoli
tteoli@litera.com
+1 336-375-2991