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Outcomes Research

Outcomes measured from the patients’ perspective

Evaluation of the effect that medicines and other healthcare interventions and solutions can have on patient-related clinical, humanistic, and economic outcomes is fundamental to the evidence generation process.  Combining and linking data from a number of sources, coupled with our HEOR experience, Excelra can help you to identify valid endpoints, biomarkers, and surrogates to inform your clinical trial design, and ultimately outcomes that are meaningful to patients, provider and payer stakeholders.

OUTCOMES MEASURED FROM THE PATIENTS’ PERSPECTIVE

There are number of elements that are important to ensure successful Market Access.
  • Overcoming the challenges of demonstrating how medicines and solutions can have positive, tangible, and incremental impact on people, and their quest for a ‘normal’ life
  • Understanding cost-regulated healthcare policies and their potential impact on your asset
  • Creating provider awareness and acceptance of your assets’ evidence, and health-system impact
  • Efficiently planning for regulatory and reimbursement submission, and approval
  • Planning for, and overcoming competition within the market/target therapy area

Market Access Challenges

Engagement and alignment of internal and external stakeholders is indispensable to this process of value generation and communication.

Evaluation of the effect that medicines and other healthcare interventions and solutions can have on patient-related clinical, humanistic, and economic outcomes is fundamental to the evidence generation process. Combining and linking data from a number of sources, coupled with our HEOR experience, Excelra can help you to identify valid endpoints, biomarkers, and surrogates to inform your clinical trial design, and ultimately outcomes that are meaningful to patients, provider, and payer stakeholders.

Evidence-Based Decision-Making

Excelra also enables identification and validation of novel patient-reported outcome (PRO) endpoints for effectively capturing health-related quality of life (HRQoL) variables which can be included in clinical trials for measuring benefits of the treatment. This facilitates early involvement of patient perspectives, and the creation of a cohesive strategy for communicating the added value to patients, physicians, payers, and policymakers.

Typical problems we can solve for our partners

  • Assess the validity of PRO tools/instruments relevant for your asset and/or therapy area/indication.
  • Development of new endpoints for inclusion in your clinical trial, including validation of these new endpoints and a plan for engagement & communication to regulators, payers, physicians & patient groups
  • Identify new biomarkers or surrogates for your asset
  • Develop a comprehensive outcomes strategy that identifies outcomes of measurable value from understanding the strengths and gaps of your product/portfolio
  • Development of new instruments with the associated dissemination plan
  • Support clinical trial design, from identifying the right endpoints and instruments to use, selecting populations, optimal trial duration (for safety & efficacy) and statistical analytical plans to interpret results and final reporting
  • Health utility studies to support inputs into cost-utility modeling