RxLogix Solutions for the Public Sector
PV Case Management – All-in-one Case Intake and Processing
PVCM is an all-in-one AE case intake and processing application. It is designed for end-to-end case processing of various type of cases including AE/PQC from multiple sources like Affiliates, Call Centre user, public reporters, medical representatives (MR), Electronic Data Capture (EDC) systems, partners, regulators, Literature data, etc., coming in any format, medium, or file type.
PV Reports – Aggregate and Ad-hoc Reporting Solution
PV Reports enables PV personnel to perform point in time access to reports supporting regulatory aggregate reporting, standard reports, data analysis, report scheduling and notification. Unlike other reporting solutions, PV Reports have been developed grounds up for drug safety and pharmacovigilance. It has features that increase the efficiency and productivity of the department, provides data consistency & accuracy and is the most intuitive and innovative reporting solution to meet the PV requirements.
PV Analytics – Spotfire Visualizations
PV Analytics is RxLogix’ pre-built visualizations solution where they are pre-built within both PV Reports and PV Signal. There are over 70 visualizations and 125+ filters for scientific data analysis. that are provided with PV Analytics, and these include the ability to further slice and dice the data. Visualizations are available on company safety data and FDA FAERS, VAERS, and Vigibase data.
PV Signal – Holistic Signal Detection and Management
PV Signal is designed as a holistic solution for Signal Detection and Signal Management activities. The system provides the ability for qualitative and quantitative signal detection as well as ad-hoc signal and topics creation and flexible Signal and Topic management and tracking. This section describes the general functionality of PV Signal.
PV Gateway – RxLogix’ alternative to Axway, for submitting your ICSRs, & Periodic reports for Regulatory submissions
A convenient and fully compliant ESTRI Gateway cloud service that can let you configure & exchange information using AS2 / AS3 between your trading partners and Authorities in minutes at a reasonable cost. A secure and economical and a single platform to submit your ICSRs, Periodic Reports and any other regulatory submissions for the complete drug life cycle.
PV Central - Case Compliance and Workload Management
PV Central unites all the key and actionable metrics to be aggregated in an easy-to-use interface, including popular mobile platforms such as iPad. PV Central’s latest version provides several out of the box key performance indicators divided into the following distinct functions. They include,
• Regulatory reporting compliance
• Productivity and cost metrics to report on the organization’s performance and productivity
• Action tracking related to PV
PV Publisher – Publishing/Submission Ready Document Authoring Solution
PV Publisher is an integrated authoring tool for Aggregate Reports and Signal Summaries. PV Publisher is designed to author automatically “draft” submission ready documents based on configurable document templates by integrating data from different system such as PV Reports, PV Signal, Clinical and so forth.
PV Quality
PV Quality is a safety data quality management solution that enables safety operations managers to detect case processing quality issues and implement corrective and preventative actions. PV Quality is designed for companies to improve data quality and drive consistency across their case processing operation in general whether it is in the outsourced or in-house processing model. In particular, CRO organizations can derive significant operational efficiencies and synergies with this solution which will benefit our clients overall.
PV Risk Manager
A robust Risk Management solution centralizing and tracking your Risk Management Plans integrated with our award-winning PV Signal and PV Reports products. Role based centralized work environment for Safety Scientists and Physicians: Provides integrated and centralized environment linking all Risk Management-Signal Management-Aggregate Reporting-Data Analysis activities. End to end RMP/REMS Management: Provides a user-friendly IT System environment to author, review and approve the RMP/REMS.
PV Clinical
PV Clinical is a PV Signal add-on to integrate clinical data source (similar to EVDAS, FAERS etc.) Provides new and efficient visual ways for signal detection and management on clinical data through a central tool for documenting outcome from clinical review. Automate and quantify the qualitative assessment of the causal relationship between a medicinal product and adverse event or reaction.