Real-World Data and Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in healthcare decision-making. According to the FDA, RWD are the data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources, while RWE is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD.

BSSI, in collaboration with pharma and biotech clients, analyzes data from a variety of sources, including:

  • Molecular data generated from public and proprietary libraries;
  • Biometric information collected through wearable and other electronic devices;
  • Electronic health records (EHRs);
  • Patient-reported data.

BSSI relies on its expertise and experience in biostatistics, bioinformatics, and data science to extract and interpret RWE from RWD. Examples of R&D efforts include:

  • Analysis of “big data” from precision medicine platforms such as Flatiron, Foundation Medicine, and Tempus;
  • Collaboration with pharma clients on integration, analysis, and interpretation of data from laboratory developed tests (LDTs) or companion diagnostics (CDx);
  • Augmenting clinical trials and drug developing using RWE.