Case Studies

A large biopharmaceutical client conducted a Phase II, 6-week, randomized, placebo-controlled, dose-finding trial to evaluate the efficacy, tolerability and safety of a new oral medication in patients with major depressive disorder who were not responding to antidepressant therapy.

A molecular diagnostics company developed a blood test to support treatment selection for patients with advanced non-small cell lung cancer (NSCLC).

Despite high effectiveness of COVID-19 vaccines in the real-world, there have been cases of fully vaccinated patients contracting COVID.

A biopharma company was conducting a Phase III study to assess the safety and effectiveness of a new COVID-19 vaccine. They needed to identify and connect to real-world data sources that would enable observation of infection rates and adverse events beyond the period of the trial.

Building External Control Arms through Real-World Data – A Phase II Oncology Case Study