The importance of RealWorld Data to healthcare

Medical care and biomedical research have experienced a data revolution in the past years, and RealWorld Data is deeply connected to it.

Clinical trials play a critical role in reviewing the safety and efficacy of drugs and are designed to meet regulatory standards, but they often take place in highly controlled settings that may not reflect the day-to-day realities of typical patient care or the life of a patient outside of the medical care system. RealWorld Data (RWD) and RealWorld Evidence (RWE) can help to provide more accurate and nuanced answers to questions about patient health and the safety and effectiveness of medical products — and to do so quickly, efficiently, and at a lower cost than has previously been possible.

But what are RWD?

Every data collected related to a health care delivery of patient health status is called RealWorld Data. It’s the data from a patient in their own environment, whether at home or at work, and in their own social context. They are routinely collected from a variety of sources, including: Electronic health records (EHRs), claims and billing activities, health-monitoring devices — also called wearables, product and disease registries, and patient-related activities in out-patient or in-home use settings.
Once they are collected and analysed, they become a RealWorld Evidence, a clinical evidence regarding the use and potential benefits or risks of a medical product. This information can play an important role in health care decisions, as it can monitor post-market safety and adverse events of newly developed drugs, can support coverage decisions and help the development of guidelines, and can be very important for medical products developers to create innovative, new treatment approaches. The study that analyses the RWD is normally called Post Marketing Surveillance (PMS) study, Phase IV of Drug Development or non-interventional clinical study.

What about RealWorld EDC?

Collecting RealWorld Data can be very expensive and time-consuming for busy doctors. For this reason, we have developed a very distinct and easy to use Electronic Data Capture (EDC) application.
For over a decade we have established a global reputation as a preferred vendor of an easy to use EDC System for Post Marketing Surveillance (PMS) studies to over 20 world leading pharmaceutical companies and CROs. Our software has been deployed successfully in more than 70 studies around the World including Ireland, Uk, France, Netherlands, Germany, Austria, Slovakia, Slovenia and Japan. RealWorld EDC is available for all language, is 100% flexible, can be tailored to any study specificities, and reduces significantly doctors’ clinic time.

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Source: U.S. Food & Drug Administration and SAS