We will navigate you through the regulatory labyrinth

 

Our services


Our experience

We have solid experience with a number of instruments for data collection from common clinical practice and innovate these all the time. We are involved in creating projects as part of which data are collected on treatment, quality of life, treatment costs and individual patient adherence. We also focus on projects that provide summary description of patient populations with a specific diagnosis, common ways of treatment for this diagnosis and disease prevalence.

 

Real-world evidence / observational studies


We select and implement the most suitable instrument for data collection and analysis from real clinical practice. We provide comprehensive services from project planning over its realization to analysis and publication.

 

Non-interventional studies (NIS) and Market research

  • -  Knowledge of the regulatory and legal environment in the Czech Republic
       and Slovakia
  • -  Creation of study protocol and statistical analysis plan
  • -  Creation of documentation for notification of NIS to the State Institute
       for Drug Control
  • -  Ensuring the course of data collection, communication with physicians
  • -  Data collection using eCRF
  • -  Data control and cleaning prior to its processing
  • -  Complete statistical data analysis
  • -  Preparation of a detailed final report, presentation, publication

Registries

  • -  Knowledge of the regulatory and legal environment in the Czech Republic
       and Slovakia
  • -  Proposal of design of the registry for a specific disease / treatment
  • -  Training and communication with healthcare workers
  • -  Ensuring the run and progress of the registry
  • -  Data control and cleaning prior to its processing
  • -  Complete statistical data analysis
  • -  Continuous data processing into the form of a detailed report, graphics outputs,
       presentations, publication
  • -  Development of automatic instruments for data control, processing
       and the presentation of continual outputs from statistical data analysis

Other activities

  • -  Analysis of health insurance company data
  • -  Analysis of indirect, social costs and loss of productivity
  • -  Projects oriented on patient-reported outcomes (PROs)
  • -  Processing of data from medical records
  • -  Real-World Evidence for medical devices