Ennov pharmacovigilance suite

PV-Express
Remote Safety Data Capture

  • Decentralized case data collection
  • Local language capabilities
  • Structured format using standard vocabularies
  • Deployed as PDF or web form
  • Optimized for smartphones and tablets
pharmacovigilance software

The Adverse Event Capture Challenge

Have you ever received an adverse event case via paper, email, or fax and as you begin retyping the information into your Pharmacovigilance database thought: “There has to be an easier way!”

Have you ever wished there was a way to collect adverse event information quickly, in the field, a local language other than English?

Have you ever missed a regulatory case submission deadline because and adverse event sat on someone’s desk or in someone’s inbox instead of being entered into your PV system?

A Lightweight and Flexible Remote AE Capture Solution

Safety data collection often involves remote personnel not located near a centralized Pharmacovigilance system, but instead at clinical trial centers, subsidiary offices and distributors. It is not always possible to provide direct access to the Pharmacovigilance database for these users considering the possible remoteness of the location or lack of internet services.

PV-Express allows such users to capture case data (in their own local language if necessary) and submit it directly to the central PV system for further processing with very little training or local IT overhead.  PV-Express can also be deployed as a fail-over solution for PV call centers as part of a disaster recovery protocol.

There are two different deployment methods for PV-Express – as a lightweight Adobe PDF form or dynamic browser-based web form.

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 while the user is offline
  • Data is submitted via a secure internet link and is transcribed automatically into the PV-Works 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 administration 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 while the user is offline
  • Data is submitted via a secure internet link and is transcribed automatically into the PV database in minutes

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

Core Capabilities

  • Remote case capture
  • Seamless upload to central PV system
  • Adobe PDF form deployment option
  • Dynamic browser-based web form deployment option
  • Custom data form design
  • Smartphone and tablet compatible
  • Uses standard vocabularies

Key Features

  • Proven software used in an a variety of deployment scenarios
  • Encourages capture of important safety data through ease of use
  • Works seamlessly with PV-Works database
  • Extends data capture to remote users and partners without training or IT overhead
  • Local language support
  • Offline data entry can be used in disaster recovery protocols

Why Choose Ennov?

Hundreds of corporate customers trust Ennov

Over 19 Years of experience providing PV solutions

150+ life science customers, many more in other industries.

Modern architecture and interface

100% web-based. Highly scalable. User-centric design

Our commitment to your success

Very high customer satisfaction, 98.5% of projects delivered on time and within budget.

Providing you freedom of choice

Available as cloud-based or on-premises deployment

You can switch between deployment options at any time.

We make you autonomous

System configuration and management require no IT skills

Improved security and optimized performance

Data is hosted locally for total flexibility. Single-tenancy minimizes business interruptions.

cloud industries

Cloud-based or On Premises

multiplatform

Multi-Platform

iso 2015 ready

ISO 9001:2015 certified

Stop wasting your valuable Pharmacovigilance resources on repetitive and low-value activities

Do not miss our tour of our innovative solution !
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