Our software may not be improving the lives of patients. But the people who use it are.
Making medicines, therapies, & treatments to save or improve the lives of patients is no small endeavor.
Equally vital in this important mission is ensuring patient safety, which is why Pharmacovigilance (PV) is highly regulated by Health Authorities around the world.
To comply with all these global regulations, it can seem like an ongoing challenge to operate under your PV system made up of a complicated web of complex PV processes and, now more than ever, a deep matrix of stakeholders and business partners from around the globe.
Between: missed deadlines, unharmonized safety data, disparate systems and sources containing key safety information, and no integrated or central source of safety information, it can be complicated to ensure global PV oversight and compliance to your processes.
Orbit Tracking Solution has been helping PV clients since 2012 by
- Disrupting their operational reliance on disconnected and passive applications to store and track compliance data, including spreadsheets, emailed documents, and scanned and rescanned paper forms
- Replacing rudimentary or manual tracking tools that can be time consuming and resource-intensive
- Improve your global oversight of PV activities, centrally tracking and capturing local variations, commitments, and activities
- Systematically achieve higher compliance levels with their PV processes
- Automatic deadline reminders and notifications help keep users aware of what they owe and to whom
- Orbit system is a validated platform for activity tracking and management specific to GVP processes (from RMPs/REMS, to aRMMs, to Aggregate Safety Reports, PSMF, PVAs, AE Reporting and Reconciliation, Health Authority Communications, and more)
- Orbit provides tailored approaches to complex compliance and safety activities with global oversight, local tasking, compliance metrics, and workflow
- Most importantly: insight into your PV processes
So while Orbit isn’t developing innovative medicine and advancing patient health, Orbit is helping the people who do: our clients, by streamlining and optimizing business processes, so our clients can spend more time focusing on their important mission, patient safety.
Senior Director of Strategy