Signal Management
Expert signal management services for pharmacovigilance delivering structured evaluation, regulatory alignment, and documented patient safety decisions across global pharmacovigilance systems.
Our End-to-End Signal Management Workflow
DrugCard delivers a structured, fully documented signal detection and management process, integrating automated detection, expert medical assessment, assessing signals, regulatory validation, and compliant reporting to support consistent safety governance across all product portfolios.
Automated Signal Detection Powered by Advanced Algorithms
DrugCard employs validated statistical models, as well as constant monitoring of multiple sources of data, in order to identify emerging safety concerns, emerging safety issues, safety signals, scientific literature analysis, as well as trend analysis, in a timely manner, in order to ensure early awareness. Spontaneous reporting and adverse events are continuously monitored in order to ensure comprehensive detection of signals.
Manual Clinical Assessment by Experienced Safety Experts
To verify that identified findings represent significant potential safety concerns, qualified safety professionals perform thorough medical reviews, looking at clinical relevance, biological plausibility, and case quality while evaluating signals. Additional information from both internal and external records, as well as a variety of data sources, are incorporated into further evaluation.
Prioritisation, Validation, and Evaluation
The identified signals are evaluated using documented methodologies in accordance with international pharmacovigilance standards, validated through signal validation and cross-functional review, and prioritized based on established regulatory criteria. Additional research is started when necessary to support a comprehensive risk assessment.
Documentation, Review, and Reporting
Every action is recorded in traceable formats, examined to make sure it complies with regulatory bodies, and promptly prepared for internal governance, inspections, and reporting. Ad hoc reports are produced as needed to support MAHs and regulatory submissions, and necessary safety-related protocol amendments are put into place after thorough safety reviews.
DrugCard Platform in Numbers
112+
Countries
Medical journals coverage
Medical journals coverage
2200+
Local journals
Continuously monitored
Continuously monitored
~2
Weeks
New country Easily Added
New country Easily Added
Automation That Speeds Up and Simplifies PV Operations
By automating repetitive processes and combining safety tasks into a single system, DrugCard simplifies pharmacovigilance operations and offers reliable, consistent, compliant, and effective oversight:
- Automated signal detection from literature, safety databases, and regulatory sources
- For a thorough analysis, case linking and integrated trend visualization tools
- Centralized monitoring of status updates and signals
- Workflows that are adaptable and compliant with regulations
- Version-controlled, audit-ready documentation
- Safe user access control and thorough activity recording
Expert-Led Manual Assessment for High-Quality Decisions
Our skilled safety staff performs thorough manual evaluations, providing precise signal interpretation and well-informed decision-making:
- Detailed clinical review of identified signals
- Assessment of case quality, plausibility, and clinical relevance
- Cross-functional validation to ensure consistent outcomes
- Prioritization and escalation aligned with regulatory requirements
- Clear, transparent documentation prepared for audit readiness
- Expert guidance supporting confident implementation of the risk management plan, ensuring teams can act decisively to protect patients and manage medicines safely
Why Choose DrugCard for PV Signal Detection and Management
DrugCard empowers pharmacovigilance teams to function with confidence while upholding compliance across all products by utilizing cutting-edge technology, professional evaluation, and regulatory-aligned procedures to deliver precise, effective, and fully documented signal management services.
Experienced Professionals
In order to provide precise signal assessments, useful clinical insights, and knowledgeable recommendations that improve patient safety across international product portfolios, DrugCard’s team combines medical, regulatory, and pharmacovigilance expertise. The safe use of pharmaceuticals is ensured by cooperation between marketing authorization holders and medical professionals.
Compliance-Ready Processes and Audit Trails
All activities follow regulatory standards, maintaining full traceability, structured documentation, and detailed audit trails to ensure readiness for inspections and regulatory authorities review.
Faster Decision-Making With Greater Accuracy
Automated detection combined with expert assessment allows rapid identification, validation, and evaluation of safety signals, supporting further evaluation, timely decisions, and effective risk management plan implementation across multiple medicinal products in a timely manner.
Scalable for Small Teams and Enterprise PV Departments
DrugCard is flexible and adaptable to team size and operation needs. It supports the needs of large departments in enterprises and small pharmacovigilance teams alike. It is highly efficient in signal detection operations and meets strict quality and patient safety requirements. The implemented procedures are highly efficient and ensure that critical operations are maintained with the least amount of disturbance.
Proven Expertise in the UK & EU Regulatory Landscape
The platform and the team work in line with the UK and EU pharmacovigilance legislations, providing practices that comply with the needs of the region, facilitate the monitoring of safety issues across the borders, and ensure the health of the population.
Who Benefits From Our Signal Management Service
Pharmaceutical Companies & Marketing Authorization Holders
Structured signal detection, thorough clinical assessment, and fully compliant documentation support consistent safety oversight across global product portfolios.
Contract Research Organizations & PV Teams
Scalable solutions simplify prioritization, enable traceable signal management, and facilitate timely decision-making for both small teams and enterprise-level pharmacovigilance operations.
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- Anwers your additional questions
- Implenetation DrugCard to your pharmacovigilance system
- Tariff plans, pricing, addional features
