Our Approach

At Delve-RW, our focus is on health and healthcare related Real-World Research (RWR), which we define as:

“The scientific process of coupling real-world data (RWD) with appropriate study design, methodology, computational analytics, and result interpretation/analysis, to produce insightful and actionable real-world evidence (RWE).”

Therefore, RWR is rooted within the definitions of RWD and RWE (provided below). 

Delve-RW's core RWR capabilities are anchored in decades of experience in the highly complementary and methodological disciplines of Epidemiology, Biostatistics and Data Science.   

Epidemiologists primarily focus on study design.  Biostatisticians contribute to the study design by determining the sample size needed for reliable results and by selecting appropriate statistical methods to analyze the data collected.   Data science compliments these activities by providing efficient methods to extract insights from structured and unstructured RWD. 

These disciplines work collaboratively to develop study protocols and statistical analysis plans (SAPs), as well as during study conduct, which includes data management, data analysis, data visualization and interpretation of results.  

RWD – “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, and data gathered from other sources (such as digital health technologies) that can inform on health status.

RWE - “the clinical evidence regarding the usage and potential benefits, or risks of a medical product derived from analysis of RWD.

https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence