for global Pharmacovigilance
& Risk Management Planning
Whether you’re tracking RMP and REMS Commitments, PV Agreements, Safety Signals or Aggregate Reports, you’ll benefit from Orbit’s transparent management of your company’s patient safety activities.
RMP Tracker distributes commitments to your local markets
PV teams are relying on passive tools, like spreadsheets and email, to manage their critical processes and commitments. This is even true in risk management, where the stakes couldn’t be higher.
Break down data silos in Orbit—where your users can easily spot deviations, copy Core and EU commitments to their local plans, and even receive notifications when there are new commitments (including Educational Materials and other RMMs) or updated plans. Empower your PV & RM teams with proactive tools that are easy and intuitive to use—the answer is RMP Tracker.
Track Signal Management activities from detection through resolution
Orbit for Signal Management provides a validated system to visibly track the flow of signal management activities occurring within your PV enterprise. From routine detection cycles through identification, resolution and closure, you’ll get a top-down, real-time managerial overview of your organization’s signal management activities at every step.
With structured workflows to help you capture your surveillance strategy, detection cycles and evaluation of detected signals, managing your process has never been simpler
Share safety documents with partners and affiliates
Modern PV teams are a complex network of local MAH’s, partners, vendors and affiliates. Many safety documents produced centrally need to be distributed to these players either for notification or local submissions.
PV teams are relying on passive tools, like spreadsheets and sending manual emails and reminders to maintain their compliance. With Orbit DocXchange, there’s a better way.
Minimize data entry for your pharmacovigilance teams
Reduce the burden of communicating around PV Agreement authoring and review by providing stakeholders with up-to-date statuses when they need them, on-demand. Integrate with existing Master Product Data lists, formalize terminology with field look-ups, and standardize the PV Agreement creation lifecycle.