Medsight Sapphire reinvents the way companies define, manage and communicate the safety profile of products. For research centers, agencies and academia, it provides one-stop platform for monitoring the benefit-risk balance of medicinal products.
All sources in one place
Medsight Sapphire lets you simultaneously perform analysis on post-marketing cases, clinical safety, literature and internal data. Bring both safety and operational data from case processing system of your choice for multi-faceted evaluation of ongoing safety and compliance concerns. Out of the box sources include FDA AERS, FDA VAERS, Maude Devices and Medline Literature.
Cumulative benefit-risk profile
Define, manage and track – ongoing, potential and missing safety risks related to company or competitor products. Medsight Sapphire’s unique portfolio lifecycle management helps you manage and publish changing benefit-risk balance in real time. Pull safety profile snapshots from different time periods to gain insight into newly discovered risks, associated analysis, assessment and communications.
Harmonize business process
Move towards paperless environment by utilizing advanced yet easy to use business process tools such as Workflow, Messaging, Shared workspace, Document control system and Querying. Reduce dependency on IT while empowering business users and achieving full traceability from sources to actions.
Discover trends ahead of time
Medsight Sapphire’s rich analytics and visualization suite offers you myriad of choices to scan all potential sources for events of interests. Discover critical insights with advanced interface and controls offering Clustered, Nested, Parallel, Steps and Multi-level drill downs.
Signal detection & management
Whether it’s ubiquitous disproportionality measures or complex data mining techniques including Multi-variate Logistic regressions, EBGM/MGPS and Mantel Haenszel ratios, Medsight Sapphire puts you in control when it comes to leveraging mix of internal and external data for the detection of hidden signals.
Streamline regulatory updates
Medsight Sapphire helps you maintain traceability between cumulative safety updates and regulatory compliance documents. Interface with existing regulatory information management system or use inbuilt version controlled repository for comprehensive tracking.
Address GVP compliance
Medsight Sapphire is your all in one solution for Risk Management, Signal management, Additional monitoring and Safety communications. Meet the new legislative requirement with a solution that matches both your immediate and long term needs.
Ease regulatory submissions
Successful completion of regulatory report submissions such as DSURs, PSURs, upcoming PBRERs and literature reports requires significant personnel involvement. Medsight Sapphire’s “Master Portfolio” gives you leading-edge in defining, generating and publishing critical reports sections.
Whether you are Epidemiologist, Safety team member, Medical reviewer, Therapeutic lead, QPPV or Regulatory affairs personnel, Medsight Sapphire’s extensible and customizable dashboard gives you readily shared and accessed information at one place.