The current state of healthcare is more specialised, competitive, and cost-conscious than ever before. To support complicated healthcare decisions and show the value of products, teams across the lifecycle require the appropriate evidence.

Patient safety, privacy, and access to affordable healthcare have all emerged as major global problems, particularly among rising nations.

RWE use is becoming more and more accepted by regulators, payers, prescribers, and patients, opening a whole new universe of opportunities.

Real-world evidence (RWE) is the clinical evidence regarding the use and potential benefits, or risks of a medical product derived from analysis of real-world data (RWD). Real-world data (RWD) has given thickness to health status of the patient and/or the transmission of health care regularly gathered from a variety of sources.

Instead of data from randomised controlled trials, RWD can be gathered from a variety of sources that are connected to health outcomes in a wide variety of patients in natural settings or methodical controlled trial settings.

RWD sources fall into the following categories:

• Clinical information can be found in electronic health records (EHRs), observational studies, and patient registries.
• Administrative/claims information can be found in claims and billing operations.
• Patient-generated data, including those from online communities, wearable technology, and home settings.
• New/non-traditional, such as social media.