Our solutions :

Pharmacovigilance - SafetyEasy PV :
- Already compliant with E2BR3 (HL7)
- E2B export and import
- E2B validation according to ICH E2B Business rules
- Integration of MedDRA dictionary
- Generation of PBRER, Signal Detection - PRR
- Bi-directional Gateway available for e-submission to Agencies (FDA, EV, )
Vigilance Software Solutions
Animal drugs - SafetyEasy VET :
- XML export and import
Quick, easy and fully validated solutions for
- Generation of regulatory reports
- Integration of VedDRA dictionary entry, import and electronic submission of adverse events

Medical devices SafetyEasy MD:

- Generation of MedWatch, eMDR (HL7), MIR XML, FORM 5, FORM 6
- Vigilance across all three classes of Medical Devices

Cosmetic products - CosmEthics :

- The first and only solution fully dedicated to Cosmetovigilance
- Generation of SUE Forms, Security report
Animal Drugs Cosmetics
- Full management of skin tests

Nutraceuticals - SafetyEasy NUTRI :

- Compliance with international regulations

- Full Global Compliance - Easy implementation &

- Healthcare certified migration
Secure hosting Easy - User friendly Human Drugs
- ISO 27001 data Center - Easy adoption - eLearning
- Full continuity and - Powerful data extraction
backup and automation of tasks

- Best in class support - Full Web SaaS

Full - Quarterly Releases - Configured easily
- Full validation Flexible and free of cost
Service dossier - Unlimited number Medical Devices Nutraceuticals
- Free maintenance of users

AB Cube, 21 Boulevard Vaillant Couturier, Contact Indian Representative:

93100 Montreuil, France +91 9810068241
www.ab-cube.com bd@thinki.in
 10 YEARS
700,000 CASES HANDLED
360 1700
SOLUTIONS INSTALLED USERS
85
CUSTOMERS IN THE WORLD

AB Cube Our Customers We love CROs !

Since 2006, AB Cube offers AB Cubes customers include pioneer At AB Cube, we understand that vigilance service providers and CROs need
software solutions and biotech companies, leading pharmaceuticals flexibility and efficiency. We have designed a solution close to your needs.
services to the vigilance and cosmetics laboratories, academics,
industry. national agencies but also many vigilance AB Cubes software solutions help you save time and maximize your Return On
service providers and CROs. Investment with:
AB Cubes team consists of - Centralized administration tools
computer engineers who The diversity of our customers ensures our - Large automation of tasks to help you save time and minimize mistakes
specialize in vigilance knowledge and experience in all areas of - Automatic generation of activity reports
software development as vigilance, whether spontaneous - Gateways with National Agencies for easy submission of cases
well as pharmaceutical notifications or clinical studies.
industry professionals. For your business to remain highly flexible and adaptable, AB Cube guarantees:
This structure helps - Speedy implementation of new databases, in 2 weeks maximum
AB Cube to meet all its - Unique implementation fee regardless of the number of databases you need
users expectations and - High contractual flexibility
needs.

Our Systems
AB Cube solutions allow to manage all vigilance processes from data entry to
AB Cubes safety solutions are: reporting:
FDA 21CFR part 11 compliant - Management of spontaneous, literature and clinical study cases worldwide
& - Audit trail / Case history for all actions performed on the system
Validated according to GAMP 5 - Edition of regulatory reports (Line listings, Summary Tabulations, CIOMS,
MedWatch, E2B XML)
The full validation dossier is - Query module with Excel file generation, link to SAS or Business Object
provided - Integration of MedDRA coding with SMQ
- Access to National Agencies drugs databases
- Fully customizable workflow
-