Safety Signal Detection Services
Signal Management in Pharmacovigilance aims to determine whether there are any new risks associated with a particular drug or if there are any changes in the previous risks associated with a particular drug. These signals can be detected from sources such as active monitoring systems, spontaneous reporting, non-clinical studies, non-interventional studies, interventional studies, meta-analyses, systematic reviews, etc.
Any signals that are arising from the spontaneous reports can also be detected through AERs systems, Ongoing benefit-risk monitoring, published articles, adverse drug reaction databases, PSURs, etc. Healthcare professionals, consumers, and patients are encouraged to report adverse reactions related to any particular drug to the national authorities to improve patient safety.
The signal detection procedure is a complex process and requires assistance from experts. Vizen life sciences will provide you with highly experienced professionals that will get the job done. We comply with regulations for drug safety and identify potential risks and develop risk minimization plans to mitigate or prevent the risks from the product’s life cycle. Our signal detection procedures are written in accordance with GVP: Module IX. We conduct signal management for products both post and pre-authorization. We collect and evaluate the data from all sources in a document and at an agreed frequency we evaluate and identify potential new signals.
Our Sources of data for the detection and subsequent evaluation include Review of individual case safety reports, aggregate reports as well as Global safety database listings and tabulations, Regulatory agency information, Pharmacovigilance Risk Assessment Committee, Information from partners, Competitor product labeling information, Emerging pre-clinical findings (e.g. teratogenic analysis, effects on pregnancy), (PRAC) findings, FDA notices, Information available from other regulatory databases, EudraVigilance Data Analysis System (EVDAS), etc. Signal recommendations and signal management tracking.
Our Services
Vizen life sciences offer services like the creation of signal detection reports and risk management. We document the evaluation and signal detection of any ongoing or new signals in a report that is reviewed and assessed by the experts. Our trained experts will handle the evaluation as it will have an impact on the benefit-risk profile of the drug. Along with the review and assessment, the aforesaid report will also consist of detailed recommendations for the signals that are confirmed. This can also be documented and discussed via the safety review committee. Our signal management procedures will make sure that appropriate action is taken in accordance with the new evidence as that will have a significant impact on the risk-benefit balance of the drug. Vizen life sciences maintain a robust and comprehensive risk management system through the life cycle of the product.
Why Vizen life sciences?
Vizen Life Sciences has highly trained professional staff that provides a variety of pharmacovigilance services to our clients. We are committed to delivering quality-driven, transparent, and, flexible pharmacovigilance services to our clients. Our robust processes are designed to help our clients through all the stages involved in the product life cycle. We provide fully managed services that leverage physician monitoring and statistical results to detect signals, decipher drug behavior, evaluate potential risks, and identify needs from potential data. Our cost-effective solutions & processes make pharmacovigilance more efficient and straightforward. Vizen delivers flexible services that match the specific requirements of our clients. Our team’s unparalleled expertise has helped us in delivering premium-quality services. We follow rigorous quality control processes to stay in accordance with regulatory standards. We identify and monitor the potential and identify risks to ensure patient safety. We are a data-driven organization that identifies new signals using automated signal detection.
Global Services
- Safety Database
- Adverse Events (AEs) Reporting
- Aggregate Reporting
- Pharmacovigilance Literature Search
- Pre-Preparation and Submission of Aggregate Reports
- Safety Signal Detection Services
- Risk Management Services
- Regulatory Intelligence
- Ongoing Monitoring Services
- Medical Devise Vigilance Services
- Pharmacovigilance Consultancy Services
Contacts
Visit Us
10th Floor Kapil Towers, Survey 115/1, ISB Rd, Financial District, Gachibowli, Nanakaramguda, Telangana 500032
Have Any Questions?
040-69441100
Mail Us
info@vizenlifesciences.com