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XZENOVA offers a wide range of post-approval services:

  • Outcome Research.
  • Strategic product positioning.
  • Application on Government formulary.

Outcomes Research

Commercial success in today's cost-conscious environment requires comprehensive data demonstrating that new products improve health outcomes and/or save cost. To this end, health economics and quality of life analyses are important for product registration and are critical to ensuring market access.

Collecting outcomes data during phases II, III, and IV clinical trial results in efficiencies in research investment. XZENOVA CLINICAL RESEARCH has the unique ability to design and carryout international outcomes research studies and to ensure the collection of relevant market data in a cost-effective manner.

  • Health Economics: Understand relevant costing methods.
  • Quality-of-life: Develop, translate, and culturally validate instruments for use in global trials.
  • Modeling Studies: Tailor core models to address national concerns.
  • Phase lllb and phase IV Programs: Design studies for simultaneous implementation in multiple countries.

Strategic product Positioning

Understanding the marketing and reimbursement environment is critical to maximizing commercial potential at each stage of the product life cycle. At the earliest stage of development, the clinical and market relevance of a product must be understood before devoting significant resources to development. In later stages of clinical development, market intelligence is more focused on creating a strategy for formulary access and rapid product acceptance.

XZENOVA CLINICAL RESEARCH provides clients with the market, competitor, and reimbursement information needed to understand the current and future environment.

Application on Government formulary

Beyond demonstrating clinical safety and efficacy to meet the FDA or TPD or worldwide approval requirements, manufacturers must also provide information to payers and providers to achieve product adoption and use. XZENOVA CLINICAL RESEARCH has the expertise to evaluate and develop a strategy to meet the provincial drug review committee on the approval of drugs on the formulary in Canada.

 
 
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