Scientific knowledge is a body of statements of varying degrees of certainty — some most unsure, some nearly sure, but none absolutely certain.

-Richard Feynman, 1955


Signal detection

Safety signal detection plays important role in monitoring a drug safety profile.It helps to monitor the products’ safety and perform proactive risk management. We are going to help you define your requirements for signal detection, guide you through the selection and system implementation process. Our offerings include development of SOPs and WPs for handling quantitative signals to stay compliant with HA regulatory requirements. Our key signal detection services include the following activities:
  • Signal generation
  • Signal assessment process (including documentation)
  • Signal monitoring (including handling of new incoming data)
  • Additional explorative data analysis techniques (including other external data sources e.g. FDA AERS database)

Training courses on Signal Detection

At the conclusion of our training courses participants should be able to know:
  • the basic concepts and methods of signal detection used in Pharmacovigilance
  • the limitations of signal detection methods applied to drug safety databases
  • the application process of signal detection methods in large databases (project settings, report generation, data visualization)
  • the methods complementing the classical signal detection methods used in Pharmacovigilance

Safety Monitoring Reports

The first step in our approach to safety monitoring reports is the creation of data analysis plans. Data Analysis Plans are well structured and defined descriptions of the evaluation of your products' safety profile. Medical knowledge, existing procedures and available data are 'combined' together and result in standardized description. This increases the efficiency and allows comparisons of performed assessments over time. Safety monitoring reports are created based on the defined data analysis plans and contain:
  • information regarding distribution of the most important variables (e.g. age, sex, time to onset, etc.),
  • tabulations with summaries (e.g. symptom counts, events vs.seriousness etc.)
  • diagrams or graphs
The aim of these reports is ongoing, comparable and consistent monitoring of your data. Our approach allows also automatic, periodic distribution of the dynamically generated reports to the defined end users (e.g.product experts).

IT Systems

    We have the experience and expertise that can help you:
  • Manage the projects for the selection and introduction of new systems, tools and procedures used for signal detection and evaluation
  • Assess business needs and define formal user requirements compliant with GCP, CFR 21 Part 11 and Signal Detection Guidelines
  • Define corresponding functional specifications
  • Evaluate available systems on the market
  • Negotiate with software vendors
  • Define business processes
  • Develop required SOPs, WPs and training documentation
  • Perform the system validation
  • Migrate the data from the legacy systems

Programming services

We offer the following programming related services:
  • Prototyping and programming of standalone or web applications
  • Database development and optimization (performance tuning)
  • Data analysis with Oracle and PostgreSQL databases
  • Data modelling
  • SQL- Query tuning

22nd 08