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Lumen Clinical

Post-marketing research

Studies evaluating product safety and effectiveness after approval.

Discuss your study

Phase IV and observational studies

Post-marketing research examines product use in everyday clinical practice and long-term safety and effectiveness data. The research question, design, follow-up period and data collection methods shape the study plan. Lumen Clinical works on Phase IV and observational research, pharmacovigilance support and related reporting activities.

  • Phase IV and observational studies
  • Long-term safety and effectiveness follow-up
  • Pharmacovigilance and regulatory reporting
  • Collection of real-world usage data

What to share for an initial discussion

We review the scope using the study objectives and available information about product use. Responsibilities for follow-up and reporting are defined in the work plan.

  • Product and the research question to be addressed
  • Proposed study design, follow-up period and sites
  • Data to collect, safety follow-up and reporting requirements