Ä¢¹½tv

CAPABILITY | HEALTH SCIENCES

Real-World Evidence Consulting

A runner stops to check their smartwatch. Ä¢¹½tv collects real-world evidence and expands data acquisition capabilities to improve healthcare.

Data-informed healthcare decisions

Ä¢¹½tv helps medical product manufacturers and healthcare professionals translate real-world data (RWD) into real-world evidence (RWE) throughout the product lifecycle to support informed decision-making, increased diversity in clinical research, and equitable and affordable access to breakthroughs in healthcare treatments and technologies.

Can real-world evidence insights improve efficiency in healthcare?

Real-world data (RWD), when analyzed with appropriate techniques, gives rise to real-world evidence (RWE) that plays an increasingly important role in healthcare decision-making. Wearable medical 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 information when analyzed carefully.

The focuses on the use of RWE to support regulatory decision-making, including evaluating the postmarketing safety and value of healthcare products and programs to provide ongoing evidence for regulatory decisions. The healthcare community is more frequently using RWE for coverage decisions and population health analytics, including treatment guidelines and decision-support tools for use in clinical practice.

Medical product manufacturers can benefit from innovative clinical trial and observational study designs, including formal causal inference frameworks, external control arms for trials, and pragmatic randomized trials to evaluate new cost-effective and innovative treatments. RWE also plays a pivotal role in addressing diversity in clinical research and improving equitable and affordable access to healthcare innovation.

The importance of real-world data

Healthcare stakeholders have a variety of research needs, and although there are many sources of RWD available, they are not all equal in quality or applicability for a given project. Our teams provide thorough data quality reviews and apply rigorous design and analysis methods to isolate causal effects in the real world. These answers can help move products to market faster, provide more relevant evidence for patients and providers, or identify and solve problems earlier.

Our decades of experience with advanced study designs and analytic techniques, along with regulators, product development, user requirements, and large data pipelines, help clients create tools for bespoke designs, data collection, and analysis that can stand up to regulatory scrutiny and payers' demands for RWE. Our broad experience with public and commercial claims data, medical records datasets, registries, and passive surveillance data enables us to address the questions needed to keep your product stewardship on track. 

How does our multidisciplinary expertise benefit you?

Our multidisciplinary teams work with clients to explore the nuances of research questions and identify datasets with the quantity and quality of information needed to address regulatory and market access questions. Not only do we consider whether a data source can provide useful information, we rely on our experience across hundreds of projects to match the right analysis with the right data, rigorously leading the field into first-time applications of methods and data sources as the problem demands. Actionable evidence is our goal.

Our consultants are frequently asked to evaluate new data sources and methods for causal inference from healthcare data. Our analytics and regulatory consultants can help clients review and prepare data to support regulatory submissions.

Research results cannot be actionable if not disseminated skillfully. Ä¢¹½tv works with clients to communicate results for target audiences, preparing findings for regulators and payers as well as presenting at conferences and publishing in peer-reviewed journals.

Ä¢¹½tv supports medical manufacturers and healthcare professionals in making data-informed decisions by helping to identify, clean, extract, and make sense of real-world data.

Experts

Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.