Post Approval Research / Post Marketing Studies / Phase IV Studies

A Phase IV study is a clinical trial, quasi-experimental study, or observational study to gather specific information about an approved drug, biological product, device, or procedure. Post-approval research is typically initiated to better understand product use in real-world situations, to obtain evidence for higher reimbursement or submission for expanded labeling, to fulfill a specific requirement of regulatory authorities, or to monitor safety of a drug or device in a larger, non-clinical trial setting.

The need for data doesn’t stop once a drug or device achieves regulatory approval; it just changes - as do your audience and your objectives. These post marketing studies involve a broader range of sites than those used for pre-approval trials and require faster, more intuitive, and more scalable systems that are also capable of delivering value back to the clinical sites. Outcome delivers successful post-approval research by offering unique scientific services, technology, and experience tailored to the intricacies of each study.