At Jeyflex, we specialize in meticulously identifying and evaluating drug safety signals, ensuring a proactive approach to addressing potential safety concerns.
Having an Understanding of Signals in Pharmacovigilance
A signal is any safety information derived from various sources, indicating a new potentially causal relationship or revealing a new aspect of a known association between an intervention and an adverse or beneficial event. Our rigorous signal management process considers the intricacies of each signal, including changes in frequency, distribution, duration, severity, and outcome of adverse reactions.
Customized Signal Management Solutions
We tailor our signal management activities to meet specific client requirements, ensuring the delivery of reliable, high-quality, and traceable data in full compliance with local regulatory guidelines. Our team of experts excels in signal management services and provides comprehensive responses to safety inquiries from Health Authorities. We offer strategic advice on approaching HA queries, critically appraise Individual Case Safety Reports (ICSRs), aggregate data and literature, and deliver thorough evaluation reports that assess the strengths and weaknesses of all reviewed data sets and sources.
Our Signal Detection Services Include
- Signal Detection: Prompt identification of potential safety signals.
- Signal Validation and Confirmation: Thorough validation and confirmation processes for identified signals.
- Signal Analysis and Prioritization: In-depth analysis and prioritization of signals based on their significance and potential impact.
- Signal Assessment: Comprehensive assessment of signals, considering their potential implications and risks.
- Authoring of Signal Management Reports: Meticulous creation of reports detailing all identified signals and their management strategies.
- Support for Labeling Updates: Assisting with necessary updates to product labelling based on identified signals and their implications.
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Our vigilant approach to signal detection and management ensures proactive risk assessment and management, fostering a safer and more secure environment for patients and healthcare providers.
Our solutions are tailored to meet your unique needs and requirements, whether you’re a small startup or a large multinational corporation. We offer a range of services, including, consulting, training, and auditing, to help you ensure that you are complying with relevant regulations and laws, and to minimize the risk of non-compliance.