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

Signal detection

Safety signal detection plays crucial role in monitoring of drug safety profiles.
It helps with decision making and performing proactive risk management.
We are happy to help you and perform health checks of your signal detection processes and systems.

Our key signal detection services include but are not limited to the following activities:

  1. Implementation of advanced signal identification algorithms
  2. Review and implementation of efficient signal evaluation and assessment process (including documentation)
  3. Implementation of ongoing signal monitoring
  4. Performance of explorative data analysis supporting signal and risk benefit assessment
  5. Signal detection in external data sources e.g. FDA FAERS database

Training courses on Signal Detection

At the conclusion of our training courses participants should be able to know:

  1. the basic concepts and methods of signal detection used in Pharmacovigilance
  2. the limitations of signal detection methods applied to drug safety databases
  3. the application process of signal detection methods in large databases (project settings, report generation, data visualization)
  4. the methods complementing the classical signal detection methods used in Pharmacovigilance (machine learning and artificial inteligence)

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:

  1. information regarding distribution of the most important variables (e.g. age, sex, time to onset, etc.)
  2. tabulations with summaries (e.g. symptom counts, events vs.seriousness etc.)
  3. 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:

  1. Manage the projects for the selection and introduction of new systems, tools and procedures used for signal detection and evaluation
  2. Assess business needs and define formal user requirements compliant with GCP, CFR 21 Part 11 and Signal Detection Guidelines
  3. Define corresponding functional specifications
  4. Evaluate available systems on the market
  5. Negotiate with software vendors
  6. Define business processes
  7. Develop required SOPs, WPs and training documentation
  8. Perform the system validation
  9. Migrate the data from the legacy systems

Programming services
We offer the following programming related services:

  1. Prototyping and programming of standalone or web applications
  2. Database development and optimization (performance tuning)
  3. Data analysis with Oracle and PostgreSQL databases
  4. Data modelling
  5. SQL- Query tuning