Real World Evidence

Conducting a randomized controlled trial is not always feasible. Even though RCTs are often considered the “gold standard” of evidence generation, Real World Evidence (RWE) can be used to address evidence gaps, while reducing overall study costs and time to market.
In addition to addressing evidence gaps, other real world evidence use cases include identifying unmet needs and patient subgroups that will most benefit from technology, gaining an understanding of patient characteristics, diagnostic markers and disease progression, and more.
When derived from RWD of sufficient quality, RWE may be used to achieve an understanding of a medical device’s benefit-risk profile (safety and efficacy) and support regulatory decisions such as approval or clearance of a new device expanding indications for use.

The availability of large and diverse health-related datasets has increased as a result of recent advances in technology and analytical capabilities as well as increased adoption of wearable devices, mobile applications, and remote access technology. This has led to the increased use of real world evidence among medtech innovators, payers, providers, and patients.
Real world data sources include disease registries, medication registries, patient reported outcomes, insurance claims, billing records, electronic health records, biometric monitoring devices, and more.
In addition to regulatory stakeholders, other stakeholders such as payers and providers rely on RWE in HTA and reimbursement decisions.

Our experts are intimately knowledgeable about where real-world data lives, governance issues surrounding RWE, how to access and transform the data and integrate data sources, and what constitutes actionable evidence for different stakeholders.
Leveraging data from disease registries, device and medication registries, patient reported outcomes, insurance and billing records, electronic health records, biometric monitoring devices, and more, our experts can help form an evidence base that addresses the demands of your stakeholders.
Utilizing RWE, we can maximize your studies designed for regulatory approval to serve a dual market access purpose.

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