Real-World Data & Evidence Consulting

Can real-world evidence improve efficiency and mitigate cost escalation in healthcare?

Real-world data (RWD) and real-world evidence (RWE) play an increasingly important role in healthcare decision-making.

Medical wearable devices, implantable data sensors, and Wi-Fi-connected home health monitoring devices, combined with electronic health records, pharmacy, and payer databases, provide an enormous amount of healthcare-related real-world data (RWD). 

The 21st Century Healthcare Act focuses on the use of these types of data to support regulatory decision-making including evaluating post-market safety and value-based healthcare initiatives, and making regulatory decisions for medical products.

In addition, the healthcare community is more frequently using RWD and RWE to support coverage decisions and to develop guidelines and decision-support tools for use in clinical practice. Many medical product manufacturers look to RWD and RWE to support innovative clinical trial designs and observational studies including external control arms, pragmatic trials, as well as large simple trials (to name a few), and to generate cost-effective, innovative, and new treatment approaches.

Real-world data and real-world evidence play a pivotal role in addressing diversity in clinical research and improving equitable and affordable access to healthcare innovation. 

The importance of real-world data.

Exponent's scientists design, collect, analyze, and critically evaluate RWD at every point in the medical product's total product life cycle to support more informed decision-making.

Stakeholders require a variety of research needs, and although there are many sources of RWD available, not all of them can withstand a thorough review of quality and be deemed fit to be used as RWE. Our teams leverage existing data sources to minimize the additional burden on patients and save time and money, helping to provide answers that can move products to market faster or identify and solve problems earlier.

Our experience with regulators, product development, user requirements, performance and process monitoring, and database design helps clients create tools for data collection that can stand up to regulatory scrutiny and payer's demands for real-world evidence of product value.

After medical products reach the market, our broad experience with public and commercial claims and medical records databases, registries, and surveillance data enables us to address questions of data quality and appropriateness.

How does our multidisciplinary expertise benefit you?

With our team of scientists and statisticians, Exponent works with clients to explore the nuances of the research questions and identify datasets or sources that have both the quantity and quality of information to address regulatory and market access questions.

Not only do we consider whether a data source seems capable of providing useful information, but we can review other uses of similar data to recommend insights about its perceived value by the target audience. For new data sources or uses, our analytics and regulatory consultants can help clients review and prepare the data to support its use for a particular purpose.

Exponent works with clients to communicate results to the target audience. Our team has been involved with preparing and presenting findings to regulators and payers, as well as presenting in public forums and publishing in peer-reviewed journals.