Safety and Risk Management

PV-in-a-Box

End-to-end PV support

Depending on your organization’s needs, you may choose to outsource niche or end-to-end pharmacovigilance services. With our modular approach everything is standardized for maximum efficiency. We offer PV-in-a-box solution for companies requiring end-to-end PV support – a shared resources and pay-per-use service offering. We employ industry-proven best practice SOPs and work instructions, along with a hosted safety database. Our quality management system and oversight ensures consistent, high quality and compliant deliverables. From a technology and infrastructure standpoint you gain by taking advantage of the investments we’ve made and the best-in-class tools we use.

By employing optimized processes and a best-in-class PV practice delivery model, we are able to reduce the ramp up time and provide a competitive transaction-based billing model (i.e. per case/per report). Our PV-in-a-Box solution comprises:

  • End-to-end PV from intake to case processing to medical review to submission. We can add aggregate safety report writing, signal detection, safety surveillance, labeling and other activities are needed.
  • Best-in-class SOPs and processes and a database hosted by us.
  • Optimized use of technology to deliver automation which ensures consistent compliance and quality; the automation layer is database-agnostic and can be deployed even with a database hosted at your end
  • Expert resources that are shared with fractional allocations based on you requirements as well as shared and appropriately apportioned costs of IT infrastructure and database and dictionary licenses . This shared service model results in near 100% utilization rate so there’s no fat there to trim.
  • Best-in-class QA and compliance. By standardizing on key metrics, project related documentation, trackers and reports, we are able to keep costs down and deliver high quality results.
  • Management oversight, along with a tried and tested governance and communication model that is optimized for a globally distributed delivery model.

This highly efficient and fungible resource model means that we can seamlessly deliver consistent and high quality outcomes across multiple accounts.