SDEA Compliance
Schedule and track regular data reconciliation between internal process owners and external partners.
Clinical databases, Safety databases, and your external partners’ databases all hold critical adverse event information, and as MAH, you are responsible for all of it. The importance of managerial oversight in highly regulated environments cannot be overstated. The increasingly distributed nature, both geographically and organizationally, of reconciliation processes is making responsive big-picture oversight harder to find.
Two-way Collaboration
Centralized reconciliation
Automated requests
Cross-functional tracking solutions.
Orbit’s cross-functional trackers connect PV teams, breaking down data siloes and supporting consistency across the organization.
Document Exchange
Automate partner document exchange based on your Safety Data Exchange and PV Agreements.
PV Agreements
Manage PVA and SDEA document lifecycle, commitments, and oversight of delegated activities.
Build with Orbit
Orbit is more than a COTS tool, it is a strategic platform. Learn more about creating new process management solutions in Orbit.
PV Agreement compliance, without the manual emails.
Schedule a call today.