Establish Signal Detection and Management for your medicinal products by using Oracle Empirica Signal
Signal detection in pharmacovigilance is the process of identifying potential safety concerns with a medication by analyzing data from various sources, such as clinical trials, patient and HCP reported adverse events, scientific literature and observational studies.
Oracle Empirica Signal is a market-leading solution for detecting and analyzing safety signals uncovering patterns and recognizing emerging trends in spontaneous adverse reaction data. After detection and analysis, Oracle Empirica Topics is used for managing signals through a workflow that keeps safety organizations compliant with EU GVP Module IX.
As a trusted Oracle Partner, Techsol has vast experience in delivering Oracle’s comprehensive suite of Signal management applications to global clients. Since 2010, we have worked extensively with many Oracle Empirica Signal & Topics clients across the globe and successfully completed several system implementation, validation, migrations and application version upgrade projects.
Oracle has recognized Techsol Life Sciences multiple times, most recently in the year 2023 for our excellence as a partner in delivering pharmacovigilance solutions globally
At Techsol, our pharmacovigilance technical team has the expertise to successfully implement, validate and continously enhance your safety signal management capabilities originating in pre- and post-market drugs, biologics, vaccines, devices, and combination products. Following are our key strengths to deliver the best-in-class services for your signal management needs:
- 15+ years experience with Oracle Empirica Signal and Topics
- Delivered over 20+ Emprica Signal Implementation & Upgrade Projects
- Have ready-to-use validation accelerators for rapid implementation
- Our 24x7 Service Desk has helped clients to optimize their Safety operations
- Advanced knowledge on statistical methods for signal management
- Recognized as a reliable partner by 40+ clients for safety data management
Oracle Emprica Signal and Topics - Technology Services
At Techsol, our Safety Technology experts have extensive practical experience to deliver the following signal management technology services for Biopharma and Medical device companies:
Complete Implementation / Upgrade and Validation of Oracle Empirica Signal and Topics for Safety Signal Management
- Signal Management Requirements Gathering
- Authoring Systems Requriements Specification
- Setup of Signal Management workflows
- Validaton Master Plan Development
- Risk Management Report
- IQ / OQ Test Scripts Preparation & Execution
- Incidents & Deviation Management
- Requirements Traceability matrix
- 21 CFR Part 11 Compliance Assessment Report
- EU Annex 11 Compliance Assessment Report
- Validation Closure Report
- End user and administration training
- Project Management
We have helped clients to establish safety signal management capabilities on both Oracle Cloud and on Techsol’s AccelSafety Cloud.
Empirica Signal & Topics End User and Administrator Training
Based on your business need, We provide comprehensive training services. Our Oracle certified SMEs can deliver the following types of training either with the classroom instructor-led model or by using the ‘Train-the-Trainer’ approach.
> Configurations Management Sessions
> Application Administrator training
> End-user training for Signal Management & Tracking
> Superuser training for System Administration
Empirica Signal & Topics Service Desk
We provide comprehensive Post-Implementation Support Services specifically designed for Empirica Cloud where patient safety, data integrity, and regulatory compliance are non-negotiable.
We offer a structured and SLA-driven support framework tailored to the needs. Our model combines functional expertise, technical depth, and compliance knowledge to ensure your application continues to operate within its validated state while supporting evolving business and regulatory requirements.
Our services include:
- Incident and Problem Management
- Regulatory Change Impact Assessment
- Configuration and Change Management
- Routine Maintenance and Monitoring
- User Management and Access Reviews
- Validation Support and Documentation
- Training and SOP Updates
Empirica Signal Custom Report Development
We specialize in delivering custom report development and analytics solutions that align with both Pharmacovigilance goals and regulatory expectations. Our services enable you to unlock the full value of safety data while ensuring data integrity, audit readiness, and compliance with global regulations.
- Regulatory & Compliance Reports
- Operational & KPI Dashboards
- Custom Safety and Clinical Analytics
- Cross-System Data Integration
- Self-Service Reporting Enablement
Common Solution FAQs
Oracle Empirica Signal is a market-leading solution for detecting and analyzing safety signals uncovering patterns, and recognizing emerging trends in spontaneous adverse reaction data. After detection and analysis, Oracle Emprica Topics is used for managing signals through a workflow that keeps safety organizations compliant with EU GVP Module IX.
All our client engagements are singularly focused in providing solutions that improve efficiency, optimizes compliance, and adds value to their teams. To ensure quality, compliance, and value delivery across our client engagements, we follow a structured approach that includes:
> Prioritizing Client’s Business Objectives: All our client projects begin off with clear identification of project scope, timelines, collaborative communication, and transparent updates on risks. We comply with industry standards, such as GxP, 21 CFR Part 11, and EU GDPR, to ensure that our services meet regulatory requirements.
> Service Quality & Risk management: We have a robust quality management system that outlines our processes for ensuring high-quality work, including document control, training, and risk management. We continuously monitor and evaluate our processes to identify areas for improvement and implement changes to optimize quality, compliance, and value delivery.
> Training and development: We provide regular training and development opportunities to our employees to ensure that they have the knowledge and skills necessary to deliver high-quality services.
> Performance monitoring: We monitor performance metrics, such as customer satisfaction and project success rates, to ensure that we are delivering value to our clients.
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