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Accelerating Evidence Generation

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 RWD/RWE goes beyond the regulatory domain. Payer demand for evidence to support a product’s value proposition is growing, in part due to proliferation of value-based reimbursement models. In addition, the 21st Century Cures Act mandates that FDA explore the use of RWE to expand indications for approved drugs and to fulfill post approval requirements.

With 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:

  1. Identifying the right data for the right purpose. UBC’s broad and agnostic perspective on the Real World Data landscape as well as experience conducting database feasibility studies enable the selection of the appropriate data to meet you research needs.
    • UBC database specialists evaluate EMR, administrative claims, and specialty databases to determine strengths and weaknesses for use in RWE studies to answer key study questions.
      1. Direct engagement and agreements with leading data vendors
      2. In-depth review of data elements and published literature
      3. Robust analysis on ‘fit for purpose’ dynamics, cost and access
  2. 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.
  3. Technology enabled curation of real world data to generate fit for purpose evidence.
    • Harmonize and link any data, anywhere, anytime with the UBC platform to yield fit for purpose insight.
      1. Bring together data from disparate primary and secondary sources including registries, EMRs, claims databases, wearables, and EDCs.
      2. Link data across sources while protecting confidentiality
    • Best in class automated analytical tools
      1. Real time analytics platform supporting self-service cohort building utilizing real-world healthcare data to provide rapid insight into the safety, utilization and value proposition of marked medications

Partner with UBC, the experts in evidence generation, to support the optimization of your approval pathways, product positioning and safety profile maturation.