Ennov pharmacovigilance suite
PV-Signal Manager
Signal Management Software
- Fully searchable repository of all signal management activity
- Dashboard provides signals in various stage of work-up “at a glance”
- Review previous data, conclusions, and evaluate the evolution of a given signal over time
- Highly configurable workflows that align with your risk management processes
- Can be integrated with Ennov PV-Analyzer for the qualitative and quantitative review of adverse event data
The Signal Management Challenge
The requirement to demonstrate a robust approach to signal detection and management is not new. More and more, global Health Authorities place greater expectations on the MAH to establish and maintain a comprehensive signal strategy, over and above the underlying obligation for regular single case and aggregate reporting. The MAH is expected to support a risk-based approach, using globally available data, across the entire product lifecycle.
Once signals are identified, via statistical data evaluation, individual case review, medical literature, social media noise, etc. they must be collected, documented and evaluated to determine their risk level and define next steps. Often this involves collaboration and communication between teams and stakeholders. But how can you ensure identified signals are worked up, aligned with your risk management process as well as ensure there is appropriate action and communication, without losing valuable time or information?
PV-Signal Manager – Workflow Driven Efficiency
In Pharmacovigilance, a signal is essentially a hypothesis of a risk with data and arguments that support it. That data can be derived from one or many possible sources. Once you detect a signal, you are obliged to determine if it is a “real signal” and if so, what are the next steps.
With PV-Signal Manager, you can easily translate your hypothesis into a risk level by quickly and effectively evaluating the data you have and incorporating the data you may need from other sources. Automatically kick-off mitigating actions and communications to ensure timely and appropriate adherence to your risk management process.
Using established process management technology, Ennov PV-Signal Manager uses configurable forms, to capture key data about your signal
- How was it detected?
- Under what circumstances does it occur?
- What is the nature and frequency of the event?
Configurable workflows guide the signal through prioritization, evaluation, classification and review. Follow-up actions are automated and aligned with your company’s risk management program, ensuring compliance and increasing efficiency.
Core Capabilities
- Configurable data collection forms and process workflows
- Signal evaluation, analysis, and categorization of potential risk level
- Dashboard for management oversight
- Built in alerts to ensure timely management of signals
- Automatically generated reports to communicate signal status
Key Features
- Streamlined signal capture and work-up
- Modern and intuitive layout
- Automatic “push” of statistically derived signal data for evaluation and follow-up
- 100% web-based
- 21 CFR Part 11 compliant
PV-Signal Manager – Part of the Ennov Pharmacovigilance Suite
Why Choose Ennov ?
Hundreds of corporate customers trust Ennov
Over 19 Years of experience providing PV solutions
150+ life science customers, many more in other industries.
Modern architecture and interface
100% web-based. Highly scalable. User-centric design
Our commitment to your success
Very high customer satisfaction, 98.5% of projects delivered on time and within budget.
Providing you freedom of choice
Available as cloud-based or on-premises deployment
You can switch between deployment options at any time.
We make you autonomous
System configuration and management require no IT skills
Improved security and optimized performance
Data is hosted locally for total flexibility. Single-tenancy minimizes business interruptions.
Cloud-based or On Premises
Multi-Platform
