Pharmacovigilance, Vigilance & Drug Safety

EViSiMa®

In today’s rapidly evolving pharmaceutical landscape, ensuring up-to-date knowledge on your pharmaceutical product’s safety profile is essential. With increasing regulatory challenges and a growing emphasis on patient safety, manufacturers need to have a robust system in place for monitoring and evaluating pharmaceutical products. Our specialized EViSiMa® service is designed to provide comprehensive consultation regarding pharmaceutical product monitoring for safety purposes, ensuring that you stay ahead of potential risks.

The EViSiMa® service leverages the extensive data on Adverse Drug Reactions and their statistics as made available in the EudraVigilance Data Analysis System (EVDAS). EViSiMa® is
short for EudraVigilance-based Signal Management and the modular structure of the service
allows for both:

• Use as source for identifying new safety signals This EViSiMa® service module takes into account statistical parameters as well as medical/scientific expertise for selecting drug event combinations that potentially represent a safety signal and trigger further verificatory actions including analyses of the underlying cases contained in EudraVigilance.
• Medical information service by use as additional dataset for validation and further assessment of your safety information obtained through post marketing surveillance.

This proactive approach not only helps in mitigating risks but also enhances your ability to respond swiftly to emerging safety concerns.

Our consultancy with regard to pharmaceutical product research and evaluation focuses on a thorough assessment of the benefit-risk profile of your medications. We understand that
each product has its unique challenges and opportunities; therefore, our tailored strategies
are designed to meet your specific needs. By integrating statistical analysis with clinical
insights, we provide you with a comprehensive understanding of how your products perform
in real-world settings.

Moreover, our signal management services extend beyond mere data analysis. Based on the medical and pharmaceutical research expertise applied in EViSiMa® services, we collaborate
closely with your team to develop actionable recommendations that align with regulatory
requirements and industry best practices. This partnership ensures that you not only comply
with existing regulations but also anticipate future changes in the regulatory landscape.

Together, we can drive innovation while maintaining the highest levels of safety in your product portfolio. Contact us today to learn more about how our signal management
services can support your goals and contribute to a safer healthcare environment for all.
Your commitment to safety is our mission–let’s work together to achieve excellence in
pharmaceutical product monitoring and evaluation.