PV-Express Remote Safety Data Capture

Ennov PV-Express

Remote Safety Data Capture

PV-Express is an extension to our PV-Works database that allows for the collection of case data from a variety of remote sources. Data can be captured in structured format using standard vocabulary lists, with very little end user training. Cases can be captured in local language and automatically translated at the time of import into the PV system. PV-Express can be deployed as a lightweight PDF file or as a dynamic browser-based web form optimized for smartphones and tablets.

General Software Description

Data collection often involves sources who are remote from the pharmacovigilance system such as clinical trial centres, subsidiary offices and distributors. It is not always desirable to give direct access to the pharmacovigilance database for these users.

PV-Express allows such users to capture case data (in their own local language if applicable) and submit directly to the central PV system for further processing with very little training or local IT overhead. PV-Express has also been successfully deployed as a disaster fall-back solution in one call centre.

There are two deployment methods for PV-Express.

Benefits of PV-Express solution

  • Industry standard – proven software used in a wide range of different scenarios
  • Validated solution – fulfill requirements of internal and external regulatory audit
  • Ensure compliance – encourage capture of regulatory important safety data by promoting ease of use
  • Integrated solution – works seamlessly with PV-Works using consistent terminology and vocabulary
  • Rapid deployment – extend data capture to new users or partners without training or IT overhead

PV-Express 1

PV-Express 1 is a lightweight PDF file that may be distributed to remote sources or placed on a website.

  • A variety of forms may be designed for different data types
  • Forms can be in any language including most European languages, Kanji, Arabic, Mandarin Chinese as well as English
  • Data forms are linked to the PV-Works database so common vocabulary lists are deployed
  • Template forms can be created with a mixture of fields, labels and logos to deliver a form designed to a customer’s specification
  • Case data is entered by the reporter (using Adobe Reader software which is both free and universally available)
  • Case entry can be completed whilst the user is offline
  • Data is submitted via a secure internet link and is transcribed automatically into the PV database in minutes
  • A copy of the original PDF is attached automatically to the PV-Works case record

PDF forms are defined using the full Adobe Acrobat program and can be deployed via a comprehensive admin tool which also tracks processing metrics. It can also be used to automatically translate form and vocabulary.

PV-Express 2

PV-Express 2 is a flexible and dynamic browser based web form that can be deployed via the internet or a company intranet.

  • A variety of forms may be designed for different data types
  • Forms can be in any language including most European languages, Kanji, Arabic, Mandarin Chinese as well as English
  • Data forms are linked to the PV-Works database so common vocabulary lists are deployed
  • Forms are designed with configurable sections and data field placement
  • Case data is entered by the reporter using any standard web browser
  • Guest or registered user access is supported
  • Native support for smartphones / tablet usage
  • Access to device functionality like voice recording and camera roll for attaching images
  • Case entry can be completed whilst the user is offline
  • Data is submitted via a secure internet link and is transcribed automatically into the PV database in minutes

A comprehensive admin tool is supplied to support form design. It can also be used to automatically translate form and vocabulary.

Technical

  • Available as cloud based solution
  • Oracle database on Windows / UNIX / Linux servers
  • Web receiver runs as a Windows Service and may be installed on a different server – often in a DMZ
  • Encryption of in-coming files and data to a 128 bit AES standard with optional support for FIPS compliance
  • Compatible with Citrix, 2X, Windows RDP and other thin client middleware
  • Agile development methodology

Customers Love

  • Local language entry: Capture case data in local language
  • Custom interface: Data entry form configured to reflect case type or user experience level
  • Smartphone / tablet ready: Browser-based deployment provides access to all device functionality
  • Rapid deployment: Extend data capture to new sources and add new users with limited training and IT overhead
  • Customer support: Experienced and knowledgeable support team on-hand to help you get the best out of your implementation and configuration

 

Core-capabilities

  • Remote case capture
  • Seamlessly upload to central PV system
  • PDF form deployment
  • Dynamic browser-based web form deployment
  • Custom data form design
  • Local language support
  • Smartphone / tablet usage
  • Offline use
  • Utilise standard vocabulary

 

 

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 are 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

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