PERIODIC SAFETY REPORTS
RISK MANAGEMENT
SIGNAL MANAGEMENT
SAFETY GOVERNANCE
PV INTELLIGENCE
QUALITY & COMPLIANCES
DRUG SAFETY SOLUTIONS
Quartica’s MARS platform provides end-to-end solutions to manage the complex drug safety business processes. The solutions can extend, enrich and enhance your existing drug safety systems (e.g. Oracle Argus) by automating downstream business processes improving quality, compliance and efficiency indicators. These solutions include aggregate reporting, signal and risk management, safety governance, PV Intelligence, Quality Compliance and others. The solutions provide the capability for contribution and collaboration across different safety domains facilitating automation and improving compliance.
Periodic Safety Reports
Aggregate reports scheduling, management and distribution processes within organizations have been fairly ad-hoc, linear and rigid utilizing a combination of localized tools, manual steps and knowledge base from individual resources. The complexity of new regulatory standards, individualized local country requirements and harmonization initiatives….
Risk Management
The current processes for documenting and tracking of signals from detection to risk categorization and management is most organizations is siloed with discrete operating functions utilizing a combination of tools and manual processes. Gap in business process and tools lead to incorrect outputs and errors incurring additional cost & re-work….
Signal Management
The current processes for documenting and tracking of signals from detection to risk categorization and management is most organizations is siloed with discrete operating functions utilizing a combination of tools and manual processes. Gap in business process and tools lead to incorrect outputs and errors incurring additional cost & re-work….
Safety Governance
Organizations internal processes to manage safety meetings for products are generally driven using ad-hoc tools such as email, spreadsheets and distributed repositories. The lack of validated product portfolio, maturity profile definition and rules defining frequency of meetings makes it difficult to manage the overall processes….
PV Intelligence
Over the last decade, regulatory agencies worldwide have gradually developed regulations and laws to regulate drug development processes in a consistent manner. As more counties adopt these practices there is a large set of rules and regulations that are both global and local in a constant state of evolution….
Quality & Compilances
Small to Mid-size biopharmaceutical organizations and in many cases large organizations often do not have transparency and visibility into quality and compliance across drug safety business processes. Data siloes across multiple systems and tools requires manual work and duplication of efforts….
Ready to Automate your Safety and Risk Management processes?
REQUEST DEMOBenefits
Key Features
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