Real World/Observational Research

The value of actual product performance

Evaluating clinical safety and efficacy is no longer sufficient for the success of your product. Further evaluation in relation to costs and effectiveness is necessary to gain real competitive advantage in the marketplace. This can be accomplished by developing appropriate study designs to prospectively collect a combination of clinical endpoints, humanistic outcomes, and health economic data simultaneously. The strategic expertise required is the application of these data to demonstrate value and secure market access and reimbursement.

Real world research specialties

i3 offers depth of experience and expertise to provide its clients with robust study design and optimized study conduct in each of the following:

• Clinical effectiveness trials – We manage the many challenges in design, conduct, and interpretation of trials.
• Patient-reported outcomes – Quality of life, patient satisfaction, and patient preferences are of increasing importance to the health care market.
• Piggyback evaluations – These yield data valuable to the demonstration of product value and to obtaining market access and reimbursement.
• Prospective observational research with integrated claims data – Studies that combine patient-reported outcomes and health care claims data are notably effective in late-phase observational research.
• Registry studies –Registries—prospective, observational studies that capture long-term, real-world data—play a growing role in today’s post-marketing world.

 
The Total Product Value System™ approach

The TPV System is i3’s systematic process by which we demonstrate the total product value and potential of biopharmaceutical products in the marketplace. The TPV approach combines the research elements of clinical research, health economics, and outcomes research within a methodological framework that maximizes the generation of relevant real-world information.

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We have honed strategies to integrate our research approach, identify stakeholder needs, and provide competitive advantage.

A track record that is unsurpassed

i3 offers an unsurpassed ten-year track record of leveraging the complex resources required to meet both scientific and operational needs presented in the collection and evaluation of real-world data to measure product effectiveness. Getting the research done internationally, efficiently, and effectively is a major accomplishment well justified by the economic value of demonstrable product effectiveness.