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Unknown risks can occur at any time when a product is marketed among the general population, so looking for new safety issues is essential.
Signal management is a vital ongoing part of pharmacovigilance involving the continuous monitoring, assessment, and discovery of potential safety concerns with a medicinal product.
It is a detailed process that scrutinises the data from various sources, including individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, scientific literature information, and other relevant sources.
Its objective is to look for patterns, circumstances, and other commonalities to uncover any safety ‘signals’ that may indicate a new medicinal product risk.
This systematic approach enables regulatory authorities and pharmaceutical companies to identify and communicate emerging safety concerns before they pose significant risks to patients.
In the EU, signal management follows a series of steps that offer a standardized approach including signal detection, validation, confirmation, analysis and prioritization, assessment, and recommendations for action.
Data Gathering: The collection and review of pre- and post-marketing data and sources.
Detection: The use of conventional qualitative and quantitative methodologies, potentially incorporating our proprietary AI Safety Database tool, iViSight. We also prepare the signal evaluation report and usually participate on a client's Signal Review Committee
Validation: The verification of the available documentation and justification for further analysis of the signal.
Analysis and Prioritization: Categorising all the risks that can significantly impact patient or public health.
Assessment: Further evaluation of the validated signal, considering all the available evidence.
Conducting a further evaluation of the data.
Monitoring the safety issue, with periodic re-evaluation (e.g., through PSURs).
Obtaining additional information, whether internal or external.
Conducting a Post-authorization Study to further understand the issue.
Creating or updating a Risk Management Plan (RMP).
Updating a Product Information/Investigator Brochure (IB).
Issuing a notification to Competent Authorities (CAs) as an Emerging Safety Issue (ESI) or as a Standalone notification.
The variation, suspension, revocation, or non-renewal of marketing authorization.
The change in eligibility criteria or other safety related Protocol Amendments.
A safety revision of the informed consent form (ICF).
Sending a Direct Healthcare Professional Communication/Dear Investigator Letter.
iVigee’s Signal Management service combines years of experience and expertise with the precision of our Safety Database analytics system, iViSight, to go beyond standard solutions with enhanced detection capabilities, efficiency, and precision.
By blending human insight with advanced technology, we can provide a comprehensive, future-ready solution for PV and Signal Management service that meets the growing complexity and volume of pharmacovigilance data.
Our approach is always focused on aligning your unique needs, while maintaining the highest level of patient safety and compliance with global regulatory standards.
Whatever your Signal Management requirements, our experienced pharmacovigilance experts can provide the solution.