SafetyEasy PV

The E2B (R3) compliant Pharmacovigilance Software

The Drug Safety Database fully dedicated to the management of Adverse Events related to pharmaceutical products.


Fully E2B (R3) compliant

SafetyEasy PV Human is a fully E2B (R3) fully compliant safety database.


Smart MedDRA coding

Automatic recoding with new MedDRA versions, SMQs in the safety database


Advanced PV

Signal detection, Regulatory Reports… Linked to iTAP, AB Cube’s triage environment.


Integrated BI solution

Business Intelligence tool integrated in the drug safety database


Integrated Workflow

A fully customizable workFlow is integrated with the drug safety database. It adapts easily to your company’s organization.


Integrated Gateway

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

Pharmacovigilance Software
Drug safety database’s Key Features
  •  User friendly Data Entry
  • E2B (R3) Data entry
  • MedDRA codder
  • Check duplicate management
  • E2B (R2/R3) validation
  • E2B (R2) import / export
  • E2B (R3) import / export
  • 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 WorkFlow 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

SafetyEasy PV in numbers …

# of Drug Safety Database Installed worldwide

# of cases handled

# of countries

AB Cube safety database are integrated but also:



  • GAMP 5 validation
  • On-line validation dossier available
  • Validation dossier updated with each upgrade
  • Minimum validation effort

Scalable & Flexible

  • Totally customizable by end users
  • Fully customizable Workflow
  • Full Query module integrated

Secured & Reliable

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

Fast & User Friendly

  • Full web (pure HTML)
  • All web browsers compatibility
  • Customization available
  • Easy and fast data entry
  • Fully customizable WorkFlow

Fairly priced

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

SaaS & On-Premise

  • Pioneer of Hosted solutions
  • On-Premise option available
  • Extensive experience in data migration

With full services

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

Want more Information about our safety database ?