Observational, or post-market studies, differ from clinical trials in that they are, by definition, non-interventional and often involve a greater number of patients and physicians over a wide area.
As a result, electronic data capture (EDC) methods developed for clinical trials are often to complex to be a practical option for “real world” situations and non-specialist operators.
Outsourcing-pharma spoke with Dominic Farmer, Cisiv CEO, about how the new Baseline Plus system can help overcome such problems and how the software fits into the growing pharmaceutical industry market for post-approval observational analysis.