Book a Demo

Book a demo

"*" indicates required fields

Consent*
This field is for validation purposes and should be left unchanged.

Download the Brochure

"*" indicates required fields

This field is for validation purposes and should be left unchanged.

Galaxy Modules

Discover the modules that can complement your safety database to reduce manual processes, streamline your PV operations, and enhance efficiency and compliance.

Galaxy modules bring automatization to reduce the risk of errors and allow your team to focus on more value-added tasks. From automatic case creation to submission of your cases to health authorities globally, discover the AI-powered modules in our AB Cube Galaxy that can transform daily operations for your safety team.

Vigilance-Hero-img

CasEasy AI – speed up case intake

CasEasy AI assistant applies Natural Language Processing (NLP) technology, allowing you to copy and paste the verbatim of your ICSR – or import it from a file – and automatically convert it into a case in SafetyEasy® Suite. The coding suggests AEs (automatically MedDRA-coded) and identifies potentially serious cases.

  • Gain efficiency in case creation from non-standard texts
  • Import pdf/jpeg/png + handwritten/unstructured docs
  • Automatic flagging of potentially serious cases

Converter – auto extract data

To save your team valuable time when entering cases in the system, our SafetyEasy® Converter tool incorporates Optical Character Recognition (OCR), allowing case information to be automatically AI-generated from uploaded forms such as CIOMS, Medwatch or SAE.

  • Reduce case intake by 70%
  • Analyses forms to extract all required data and enters datapoints directly into cases in SafetyEasy®

Literature Manager – optimise screening

To optimize surveillance, Literature Manager saves articles screening time. This end-to-end tool – automatically connected to PubMed – helps you find, analyse, review & create potential cases.

  • Unlimited number of products monitored included
  • Triage using advanced AI sorts only potential PV cases, reducing screening volumes
  • Abstract processed through CasEasy AI, creating the case in SafetyEasy®

Webform – standardized AE forms

Standardize your adverse events reporting forms. Create your own form, directly mapped to SafetyEasy® to allow automatic case creation.

API Connect – seamless data integration

SafetyEasy®’s standard API enables you to work on seamlessly integrated tools: you can leverage it to connect SafetyEasy® to any of your external systems: eCRF, MedInfo, CRM, Business Intelligence tool etc.

iTAP® – audited processing & filtering of ICSR batches

ICSR Triage Assessment and Processing enables you to import large batches of AE cases (for eg. Eudravigilance MLM or L2A cases, or cases sent by partners) into a buffer zone, and apply filters to seamlessly import only relevant cases into SafetyEasy®.

  • Management of XMLs E2B(R2) and (R3) formats
  • Viewing and filtering capabilities on all cases’ fields
  • Full audit trail of activities & import/rejection decisions
  • For CROs, possibility to use iTAP for triage activities across several client organizations

MedInfo – linked to your AEs

Track your patient and health professional questions.

  • Immediately push vigilance-related questions to your SafetyEasy® safety database. MedInfo can be used as a standalone or integrated to SafetyEasy®.

Intake – easily track imported cases

Import your cases in any format. Intake is a buffer zone where the cases can “transit” for review and confirm a potential AE or any other vigilance case, before being injected automatically in SafetyEasy®. With Intake, you can easily track imported and rejected cases.

Gateway – integrated file transfer

Make connection to the health authorities easier thanks to SafetyEasy® Inbound and Outbound Gateway.

Automatically transfer your vigilance files to and from partners: Health Authorities, your partners’ safety systems, or any other systems supporting AS2 transfers (eg. EDCs or others).

Mono-directional gateways provide you with an ACK on receipt. For the bi-directional MHRA gateway the agency sends the cases directly logged in into their platform and you can simply send your reports and cases.

Business Intelligence – boost compliance

Powerful BI solution using the latest Qlik Sense® technology to help you visualize your data, boost your case analytic capabilities and improve signal detection with advanced dashboards:

  • Workflow overview & case distribution
  • Case: high level & time exploration
  • MedDRA exploration
  • Pivot table
  • Compliance overview

Central DB Manager – effortless admin

Streamline all your databases management and administration with a complete overview of all your sponsors DB, query of all your databases at once, create users rules.

Explore the AB Cube Galaxy – download the brochure

Download Brochure

ALWAYS COMPLIANT

We’re making validation easy

Streamline drug safety operations with a system dedicated to the management of Adverse Events related to pharmaceutical products.

Galaxy modules validation

All Galaxy modules, including those containing AI technology, are validated in accordance with ISPE GAMP® 5 – Appendix D11 (A Risk-Based Approach to compliant GxP Computerized System, Second Edition) which focuses on AI and Machine Learning. All quality documentation is available within the SafetyEasy® Suite Document Management System (DMS) to assist with preparation for audits from relevant Health Authorities.

AI Act
According to EU AI Act, the risk classification of our AI systems is classified as “minimal or no risk”. AB Cube’s AI tools therefore fall outside of the current scope of obligations under the EU AI Act
Robustness & security
All of the AI tools in the AB Cube Galaxy are continuously monitored to ensure that each AI system performs as per its intended use. The AI systems are continually tested for data quality, and our AI tools are fully compliant with GDPR regulations – with no customer data stored by the AI system.