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SafetyEasy PV

The E2B (R3) compliant Pharmacovigilance Software

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

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Fully E2B (R3) compliant

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

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Smart MedDRA coding

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

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Advanced PV

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

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Integrated BI solution

Business Intelligence tool integrated in the drug safety database

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Integrated Workflow

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

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Integrated Gateway

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

Pharmacovigilance Software
Gateway
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:

Compliant

Validated

  • 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 ?

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AB Cube : The Safety Software Company

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