PV-Analyzer : signal detection and data mining tool

PV-Analyzer

Signal Detection and Analysis Software

Implementing a process to identify potential signals is essential. PV-Analyzer is a comprehensive signal detection and data mining tool. The application, designed for use out-of-the-box by business users, offers a broad array of statistics as well as powerful data cubing and visualisation functionality.

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pv-express

General Software Description

Your pharmacovigilance database contains a wealth of important information about your products. The extensive mining and reporting capability of PV-Analyzer brings this knowledge to your fingertips allowing you to prepare detailed analyses and graphical outputs for both internal and external use.

With PV-Analyzer you can rapidly calculate key statistical measures that are widely used by regulatory authorities such as PRR, ROR, and MGPS and apply smart stratification to examine the database and detect where customizable thresholds have been exceeded.

The application integrates easily with PV-Works, other PV solutions, and various external data sources to increase flexibility in preparing such important metrics.

Benefits of PV-Analyzer solution

  • Industry standard – proven software used by key regulatory authorities to perform signal detection
  • Validated solution – fulfill requirements of internal and external regulatory audit
  • Ensure compliance – implement a structured signal detection procedure and track review of analysis
  • Integrated solution – capable of drug safety, product defect and even technical enquiry data
  • Optimized for business user – empower your product experts to perform signal detection without persistent input from IT

Data Mining

  • Run flexible queries to return results in a grid that can be sorted, filtered, grouped, printed, and exported
  • A three dimensional cube / pivot table which allows users to “slice and dice” data “on the fly”, comparing and sub-setting data at will
  • Examine case data from the perspective of product – sign pairs
  • Apply multiple mathematical functions such as count, sum, average, max / min, standard deviation etc.
  • Built-in “top-n” results function

Statistical Calculation

  • Create frequentist statistics such as PRR, ROR, OE, Chi-Square
  • Create Bayesian statistics such as EBGM, MGPS, IC and confidence intervals
  • Define both nominator and denominator source data sets
  • Aggregate clinical signs into different MedDRA / VeDDRA levels e.g. SOC, PT
  • Group target products into logical subsets e.g. by generic nameor product family
  • Analyze the effects of interacting products
  • Analyze by batch number
  • Stratify case data by any number of factors such as country, date, gender, dosage form as well as user-defined groups e.g. age / weight ranges (or species / breed for veterinary data)
  • Identify potential signals against customisable thresholds
  • Compare results against previous calculations and see visual indication of changing trends
  • Drill down from a statistical result back to PV-Works in order to view the contributing cases
  • Statistical results are stored in the PV-Analyzer database for tracking review comments

Graphical Reporting & Export

  • Graphical presentation of all base data and derived results
  • All grid and cube results can be printed or exported to Excel
  • Export potential signals for workflow managed review and processing
  • Watch-list function to monitor and alert users of specific data situations
  • Advanced report writing tool to support the ad-hoc development of other required outputs

Configuration

PV-Analyzer includes a wide range of configurable options to give the business users power to explore the safety data without any support from their IT colleagues, e.g.:

  • Define configuration groups using almost any parameter e.g. regions, age groups, breed groups (for veterinary data) and use these either on the cube or in statistical analysis
  • Standardize the names of concomitant medications to overcome spelling variations in the case data
  • Define expected clinical signs per product and sub-set statistical results into labelled / unlabelled groups
  • Define alert thresholds for each product and apply these to statistical results to identify more likely signals

Technical

  • Available as cloud based solution
  • On-site deployment scalable from single PC to corporate solution
  • Oracle database on Windows / UNIX / Linux servers
  • Separate database to PV solution to optimize performance
  • Compatible with Citrix, 2X, Windows RDP and other thin client middleware
  • Agile development methodology

Customers Love

  • Data cube: Explore and manipulate data relationships with simple drag-and-drop interface
  • Statistical stratification: Apply customised stratification to produce comparable statistics
  • Visual indicators: Identify potential signals against customisable thresholds and see changing trends when comparing with previous calculations
  • Graphical output: Generate graphical outputs and output for use in reports and presentations
  • Customer support: Experienced and knowledgeable support team on-hand to help you get the best out of your implementation and configuration

 

Core-capabilities

  • Flexible queries functionality
  • Three dimensional data cube / pivot table
  • Create frequentist statistics such as PRR, ROR, OE, Chi-Square
  • Create Bayesian statistics such as EBGM, MGPS, IC and confidence intervals
  • Configurable nominator and denominator source data sets
  • Apply customised stratification to produce comparable statistics
  • Identify potential signals against customizable thresholds
  • Compare results against previous calculations and see visual indication of changing trends
  • Store statistical results and track signal review
  • Extensive graphical presentation options
  • Direct export to Excel
  • Advanced report writing tool

 

 

clood

Cloud-based or On Site

plateforme

Multi-Platform

iso-site

ISO9001:2015

Ennov PV provides a comprehensive solution to the management and reporting of human and veterinary adverse events.

PV-Express

Remote safety data capture.

PDF file or dynamic browser-based web form.

PV-Entry

Web based pharmacovigilance case data entry.

Efficient and configurable web interface. Speech to text.

PV-Works

Complete pharmacovigilance database with configurable workflows and reporting.

PV-Analyzer

Signal detection and analysis.

Out-of-the-box use by business users.

Broad array of statistics. Powerful data cubing and visualisation.

Why Choose Ennov ?

Complete pharmacovigilance solution

  • Comprehensive features
    • Intuitive case entry
    • Validation workflows
    • Reporting to authorities
    • Advanced analysis
  • Manage any product type
    • Human drugs
    • Pharmaceutical drugs
    • Materiovigilance

We respect your freedom of choice

  • Available as cloud or on premise. You can switch between options at any time.
  • If cloud based we offer single-tenancy to minimize version upgrade risks and validation upgrades. Data is hosted locally for total flexibility, improved security and optimized performance.

Structuring AND intuitive

Ennov PV Works interface

From case entry…

PV- Ennov PV Graph

… to reporting …

PV- Ennov PV Graph

… and statistical analysis

Book a demo of Ennov PV Analyzer

To book a demo, the best way is to fill the following form. You will be contacted very quickly by our team.

Or

Send us a mail at: contact@ennov.com.

Or

Contact our European office.

Or

Send us a letter at:

Greensboro USA

Ennov USA
2311 West Cone Blvd, Suite 234
Greensboro, NC 27408

Or

Paris – Headquarters

Ennov Paris
251 rue du Faubourg Saint Martin
75010 Paris – France

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