SafetyEasy PV Human

The Pharmacovigilance Software

The Pharmacovigilance software fully dedicated to the management of Adverse Event related to medicinal products.

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E2B R3 fully compliant

SafetyEasy PV Human is already E2B R3 HL7 fully compliant.

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Full MedDRA services

Automatic recoding and SMQ

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Integrated BI solution

Business Intelligence tool integrated

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WorkFlow integrated

A fully customizable workFlow is integrated with SafetyEasy. It can be modified to follow with ease your company organization.

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Gateway integrated

Our Gateway is available to exchange with EMA and FDA. SafetyEasy could be used with Web Traders too.

Pharmacovigilance Software
Gateway

SafetyEasy is more than a Pharmacovigilance E2B R3 database

Compliance

Validation

  • GAMP 5 validation
  • On-line valdation dossier available
  • Validation dossier updated
  • Minimum validation effort

Full services

  • Transparency (Access to online Document Management system)
  • eLearning
  • 24 / 7 hotline
  • Validation software
  • Ticketing software

Secured & Reliable

  • HIPAA compliant
  • SSL web access
  • BackUp & Restore
  • 99,99 % SLA guaranteed
  • 21 CFR part 11 Full Audit Trail
  • ISO 27001 data center (Tiers III plus)

Fast & User Friendly

  • Full web (pure HTML)
  • All web browser compatibility
  • Customization available
  • Easy and fast Data Entry
  • Fully customizable WorkFlow

Fair pricing

  • No hidden costs
  • Clear and adaptative offer (From Basic to Professional)
  • Unlimited number of users

SaaS & On-Premise

  • Hosted solutions
  • On-Premise solution
  • Great experience in data migration

Scalable & Flexible

  • Full Query module integrate
  • Totally customizable by end users
  • Fully customizable Work Flow
Pharmacovigilance software’s Key Features
  • User friendly Data Entry
  • E2B R2/R3 Data entry
  • MedDRA codder
  • Check duplicate management
  • E2B validation
  • Attach document
  • Narrative template generation
  • Follow Up Management

 

  • MedDRA SMQ
  • IME management
  • Query module intergated
  • Calendar (Submission & Follow-up management)
  • Automatic Mail generation
  • Task Scheduler (Change MedDRA version for exemple)
  • CIOMS I, MedWatch, …
  • XML E2B R2/R3 HL7 Import / Export
  • Line-Listing (PSUR, PBRER, DSUR, …)
  • Summary tabulation (PSUR, PBRER, DSUR, …)
  • Signal detection : PPR, Qualitative
  • Full Work Flow management
  • XEVMPD IMPD dictionaries management
  • Reportability matrix management
  • Users administration
  • User’s group rights management
  • EudraCT import
  • AB Cube’s Gateway or Web Trader integration
  • Link with SafetyEasy MI
  • WHO Drug Dictionnary integration
  • XEVMPD / IDMP integration
  • EudraCT link

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