The pharmacovigilance software SafetyDrugs supports pharmaceutical organizations in the comprehensive management of ICSRs and in compliance to international regulatory requirements, ensuring operational stability, data security and traceability of activities.
Digital Products
SafetyDrugs
OUTCOME
Manage drug safety with reliability, control and compliance
A solution that enables complete control of reporting, reduces operational inefficiencies and ensures traceability and reliability in business processes.
THE PROBLEM
Pharmaceutical organizations must handle large volumes of safety reports and comply with strict regulations.
Common problems
Complex management of adverse events
Stringent regulatory requirements
Need for timely transmission of reports to authorities
High risk of manual errors and unstructured processes
Inspections by regulatory authorities
Without dedicated pharmacovigilance software, management becomes difficult and risky from a regulatory perspective.
THE SOLUTION
Modular and Scalable
SafetyDrugs is a pharmacovigilance safety database designed to manage the entire life cycle of Individual Case Safety Reports (ICSRs).
The platform enables the collection, analysis and transmission of adverse events in accordance with international standards by supporting both clinical studies and activities of post-marketing surveillance.
How it works
Collection
Registration and management of adverse event reports from clinical trials, scientific literature, and spontaneous reports.
Management
Structured workflow for classification, coding and monitoring of pharmacovigilance cases.
Transmission
Sending ICSRs to regulatory authorities and partners through gateway systems and standard protocols.
Analysis
Production of regulatory reports and data analysis to monitor safety and compliance.
WHAT IT INCLUDES
A comprehensive platform
SafetyDrugs offers a comprehensive platform for pharmacovigilance management:
Adverse event and ICSR management with customizable workflow
Transmission to regulatory authorities and partners
Integration with Business Intelligence
Signal Detection analysis using indicators of statistical disproportionality of data
Extrapolation of line listing and regulatory reports
CASES OF USE
The adoption of SafetyDrugs brings strategic benefits beyond just technology.
Companies
pharmaceuticals
pharmaceuticals
Drug safety management and monitoring of adverse events.
CROs and research organizations
Supporting pharmacovigilance data management during clinical trials.
Pharmacovigilance Service Provider
Support pharmacovigilance management on behalf of their client pharmaceutical companies.
Business Impact
Organizations that adopt the SafetyDrugs safety database can obtain:
Greater control over pharmacovigilance processes
Reduction of manual errors
Improving regulatory compliance
Increased operational efficiency
COMPLIANCE AND SECURITY
Designed according to security and governance-by-design principles.
SafetyDrugs is designed to operate in highly regulated environments and complies with international standards including:
ICH E2B (R3)
Good Pharmacovigilance Practices (GVP)
Good Clinical Practice (GCP)
GDPR
CFR 21 part.11
Pharmacovigilance software ensures data security and integrity, traceability and support for regulatory inspections.
WHY ABACUS
An approach based on a structured operating model
SafetyDrugs is developed by Max Application, a company of the Abacus Group specializing in solutions software for regulated environments and advanced management systems.
Abacus’ experience in managing critical systems ensures technological reliability, data security and business continuity.
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SOLUTION OVERVIEW
A comprehensive overview
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