Non-interventional studies

Over the past 15 years, Metronomia has gained vast experience in the planning and conducting of non-interventional studies (NIS). For each NIS, our focus is on credibility and quality, so that we can draw valuable and usable conclusions from the collected data.

 

NIS are efficient instruments. They come to comprehensive conclusions regarding the application as well as the efficacy of pharmaceuticals by means of a representative group of patients. NIS include Post Marketing Surveillance (PMS) studies, cross-sectional, longitudinal and observational studies. 

Services for non-interventional studies

  • Planning and setup of study protocol or observation plan, including biostatistical considerations
  • Development of all study-related documentation according to national requirements
  • Submission to responsible national Ethics Commitees (EC) and responsible local ECs for favourable opinion
  • Set-up of eCRF or alternatively development of paper-based CRFs and study folders (including printing administration)
  • Logistics
    • Distribution of documentation
    • Mailshots
    • Newsletters
    • Investigator remuneration
  • Project management
    • AE management
    • Status reporting
    • Quality control
  • Helpdesk and support
  • On-site monitoring
  • Data management and data validation
  • Statistical analysis, reporting and preparation of publications
  • Pharmacoeconomic analyses