Real World Consulting

Real-world Data (RWD) and Real-world Evidence (RWE)

The FDA has a long history of using what we currently call “real-world data” (RWD) and “real-world evidence” (RWE) to monitor and evaluate the post-market safety of approved drugs. RWE has also been used to support efficacy, but on a more limited basis. Advances in the availability and analysis of RWD have increased the potential for generating robust RWE to support FDA regulatory decisions. The FDA is committed to realizing the full potential of fit-for-purpose RWD to generate RWE that will advance the development of therapeutics and strengthen regulatory oversight of medical products across their lifecycle.

What is RWD and RWE?

Real-world data refers to data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, data derived from observational studies, patient-generated data, and data gathered from other sources (such as digital health technologies) that can inform on health status.

Real-world evidence is the clinical evidence informing the use of a medical product resulting from the analysis of RWD. Some trials may use a hybrid design, collecting a combination of RWD and more traditional forms of trial data.

Real-World Project Management

QualMedica Clinical Consulting provides project management to optimize your RW projects and power your RW team to success.  Our program mentors integrate into your team structure and provide consistent leadership and project oversight to identify resource gaps that might derail or delay your RW project.

Areas of Expertise: