Real World Evidence

Foundation of a Market Leading Real World Evidence Strategy

Regulator and payer constituencies have recognized the immense potential of real world evidence (RWE) in accelerating our ability to answer important questions about the safety and effectiveness of medical treatments. The opportunity to capitalize on real world data (RWD)/RWE goes beyond the regulatory domain. Payer demand for evidence to support a product’s value proposition is growing, in part due to the proliferation of value-based reimbursement models. In addition, the 21st Century Cures Act mandates that the FDA explores the use of RWE to expand indications for approved drugs and to fulfill post-approval requirements.

With more than 15 years in evidence generation, UBC is poised to address the challenges of this emerging landscape and accelerate the time to generate meaningful and clinically rich evidence by:

Identifying the right data for the right purpose.

UBC’s broad and agnostic perspective on the RWD landscape, as well as experience conducting database feasibility studies, enable the selection of the right data for the right purpose.

UBC database specialists evaluate electronic medical records (EMR), administrative claims, and specialty databases to determine strengths and weaknesses for use in RWE studies to answer key study questions. We provide:

• Direct engagement and agreements with leading data vendors.
• In-depth reviews of data elements and published literature.
• Robust analyses on ‘fit for purpose’ dynamics, cost, and access.

Gather evidence in a real-world setting.

UBC is an industry-recognized leader in innovative observational and pragmatic study design and execution. UBC excels in:

• Study design consultancy for optimized site selection and accelerated patient enrollment.
• Novel evidence generation through collaboration with healthcare networks, disease advocacy groups, and providers.
• Virtual/Decentralized study design, incorporating connected devices and wearables, and leveraging UBC’s in-home nursing network.
• Embedding research into clinical workflow and capturing data prospectively from the point of care.
• Direct EMR data harvest.

Technology-enabled curation of RWD to generate fit-for-purpose evidence.

UBC’s technology allows you to:

• Develop in-silico study designs and external control arms.
• Align therapeutic ‘research-ready’ data marts.
• Harmonize and link any data, anywhere, anytime, with the UBC Mosaic platform to yield fit-for-purpose insight.
• Bring together data from disparate primary and secondary sources, including registries, EMRs, claims databases, wearables, and EDCs.
• Link data across sources while protecting confidentiality.
• Generate real-time analytics to support self-service cohort building, utilizing real-world healthcare data to provide rapid insight into the safety, utilization, and value proposition of marked medications.