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Integrate Real-World Data

Marvin and SafetyEasy®:

Seamless integration for faster, smarter Pharmacovigilance

Transform Any AE Source
Automatic Case Creation
Ongoing Data Reconciliation
Reduces Manual Workload
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Safety Workflow with Marvin and SafetyEasy®

AB Cube automates and reconciles entire Safety Workflow process – reducing data entry, reconciling in real-time and providing full audit trail.

SAE Intake
Structured entry in Marvin, timestamped from awareness
eCRF Entry
Intake is the eCRF entry, done once
No back-entry step
SAE to Case Creation
Auto-created from EDC, mapped to ICSR in SafetyEasy
No duplicate entry, no immediate divergence
Query Management
Flagged at case creation, all three teams in one platform
Resolved faster, no email threads
SUSAR Submission
Filed on already-aligned eCRF and PV data
No post-submission corrections
Reconciliation
Continious field-level comparison, divergences flagged live
Preventive, not corrective
Oversight & BI
Cross-study dashboard for conversion, reconciliation
Issues surface before they escalate

Safety Management, Smart Workflows, Natively Integrated

Features of Marvin and SafetyEasy®

Data Management
Regulatory Reporting
CasEasy
Converter

Data Management

  • E2B R2/R3 import, export, and validation
  • Gateway integration
  • MedDRA & SMQs
  • IME list support
  • HL7 Gateway for medical devices
  • MedDRA recoding
Data Management

Regulatory Reporting

  • PSUR, DSUR, PBRER, PADER
  • MDCG 2020-10/2, MDCG 2024-04
  • Ad-hoc queries
  • IME list support
  • Customized reports
Regulatory Reporting
NLP-Powered Case Structuring
CasEasy uses advanced Natural Language Processing (NLP) to convert unstructured safety narratives into structured ICSRs. Whether you copy-paste verbatim text or import files, CasEasy intelligently extracts key data fields and maps them directly into SafetyEasy®—accelerating intake and reducing manual errors.
GenAI-Powered Form Extraction

Converter

The Converter module uses GenAI to transform CIOMS, MedWatch & SAE forms into structured case models. It transforms static documents into actionable safety cases, enabling automated intake from legacy formats and scanned submissions.

Enhanced Patient Safety and Reduction of Operational Cost

AB Cube automates and reconciles entire Safety Workflow process – reducing data entry, reconciling in real-time and providing full audit trail

One source of truth

Structured SAE intake in Marvin EDC with timestamps from awareness. Audit ready

Reconciliation

Continiously field-level comparison, divergences flagged live
Preventive, not corrective

Streamlined Workflows

Auto-create SAE from EDC data entry.

No duplicate entry, no immediate divergence

Oversight

Cross-study dashboard for conversion, reconciliation

Issues surface before they escalate

Compliance & Security by Design - Built on a robust, pre-validated framework aligned with GCP and 21 CFR Part 11 Standards.

Full Compliance with GCP and 21 CFR Part 11 Standards

Our solutions provide complete compliance with Good Clinical Practice (GCP) and 21 CFR Part 11, featuring secure eSignatures and audit trails that simplify regulatory audits and enhance research credibility.

GDPR-Compliant Data Handling and EU Data Storage

We host data securely within the EU, ensuring compliance with GDPR standards for academic institutions in Europe and securing sensitive patient data with SSL encryption.

Secure Audit Trails and Role-Based Access

Maintain detailed audit trails for transparency and role-based access control to safeguard against unauthorized access, ensuring that only approved personnel handle sensitive information.

Trusted by Industry Leaders

By collaborating with the Marvin team over several years acromion’s data management team has acquired the skills and knowledge of implementing complex and challenging clinical protocols on Marvin, while adding its expertise in clinical data validation, safety reporting and CDISC competence to the final product. All the time we perceived a cooperative, fast and qualified partnership with the Marvin team.

Oana Braun, Founder acromion

We think that Marvin is very flexible. It allows us to manage very complex amendments and study design. It’s also very easy to integrate with external parties (using real web services and the REST technology).”

Benoît de Malglaive, Team Leader EDC Specialists, IDDI

We are currently conducting six oncology studies using Marvin, including a Phase III study. We were quickly convinced by Marvin, as the system is extremely user-friendly. We particularly appreciate the modular structure, which can be flexibly tailored to the requirements of our studies. We don’t have to use all the modules, but it’s reassuring to know that everything is integrated. If something changes during the course of the study, the system can easily be adapted. Marvin has optimized our processes and is extremely user-friendly – it’s easy to navigate and provides everything you need.

Michael Fuchs, Leiter Studienzentrale der Deutschen Hodgkin Studiengruppe (GHSG)

I had worked at two companies involving EDC systems. We are lucky and honored that we are in the position using Marvin with our studies. Marvin is a marvelous system.

Naoko Nakagawa, Data Manager, I’Cros Japan