Analytics & Reporting
Foresight has extensive experience with implementing PV data marts, creating custom reports, configuring out of the box reports (e.g., aggregate reports) and with providing on-going support for ad hoc queries and reports via retainer based managed services contracts. Foresight has many experienced bi-lingual (English and Japanese) resources that understand both global and Japanese regulations.
Foresight’s PV Query (PVQ) solution is the first commercially available solution to support creation of ad hoc queries and reports directly by end users of the safety system — not just power users or IT resources within a central reporting group. PVQ comes in standard and professional versions, to accommodate the needs of small to large companies. PVQ professional provides a feature rich PV data mart as well as access to real-time data, thus allowing it to meet the full range of performance and business requirements for companies with more than 50,000 cases. PVQ and PVQ-J are available both on premise and in the Foresight® Cloud and work against single and multi-tenant versions of Argus.
Foresight’s PV Monitor® (PVM) solution is the only PV compliance monitoring data mart that supports the full life cycle of monitoring for compliance to internal SOPs and regulatory ICSR submission requirements, plus captures reasons for lateness and manages the entire CAPA creation and implementation process. PVM provides best practice processes and reports for monitoring PV compliance — based on a combination of best practices from 7 of the top 10 pharmaceutical companies.
PV Data Marts
Foresight has extensive experience with implementing COTS PV data marts from Oracle and Aris Global. In addition, we have performed numerous projects to design and implement new custom PV data marts or to enhance existing custom data marts. The safety data marts provided by safety database vendors often are lacking required calculated fields, other standard fields, filters, etc. Foresight has extensive experience with updating pre and post ETL logic and with modifying the out of the box models/universes to meet additional requirements of our customers.
Custom Report Development
Foresight has a proven methodology for capturing business requirements, performing a fit-gap assessment, designing and then implementing custom reports in both English and Japanese against multiple commercial safety databases as well as against custom safety databases. For estimating and prioritization, reports are first analyzed to determine which reports are out of the box (“fit”) versus those that must be created (“gap”) and then the custom reports that must be developed are categorized as simple, medium, complex and very complex with a proven estimating model for each category and a fixed fee per report complexity. We are equally skilled in Business Objects™, Cognos™ and OBIEE to create custom data marts and reports that meet your additional needs.