Real World Evidence (RWE)

The market demands evidentiary support of convincing, real world clinical and economic data to establish credibility and influence market adoption.
Real world evidence (RWE) has applications in both regulatory and reimbursement decisions and can be used to inform clinical guidelines. It can be used to identify unmet needs, gain an understanding of patient characteristics, diagnostic markers and disease progression, address evidence gaps when randomized control trials (RCTs) are not feasible, bolster value propositions, and more.
As a result of advances in technology (e.g., remote monitoring technologies) and analytical capabilities – especially those employing artificial intelligence (AI) over recent years, there are large, diverse health-related datasets readily available, and the use of RWE in decision-making is therefore increasing.

Making use of data that’s already been generated in the healthcare system (through randomized control trials (RCTs), pragmatic studies, observational studies, and more) to more efficiently generate evidence, real world studies can reduce the time and cost to generate evidence for regulatory and reimbursement decisions.
Utilizing real world data (RWD) allows you to achieve outcomes that may not be feasible from the gold standard of evidence generation – randomized control trials (RCTs).
The 21st Century Cures Act, designed to improve efficiency and speed the rate at which medical advancements become accessible to patients, established a framework for use of RWE in supporting regulatory decision making in the US, but this framework does not apply to medical devices (it only covers label extensions and post-approval studies for drugs and biological products).

Our experts can help you select a real-world study model, and develop a research protocol, dependent on the research question you’re seeking to answer.
We can identify appropriate sources of RWD for your study.
Leveraging data from disease registries, device and medication registries, patient reported outcomes, insurance and billing claims, electronic health records, biometric monitoring devices, and more, our experts can help generate the evidence your stakeholders need.

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