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HEALTH OUTCOMES RESEARCH
We support our clients in performing all aspects
of health outcomes research including protocol development, study
site identification, investigator training, study monitoring, data
management and regulatory management.
Prospective Health Outcomes Studies:
- Piggy Back Phase II/III Studies: Studies where health outcomes
(quality of life, patient satisfaction, care-giver burden, patient
preference) endpoints are added to a Phase II/III clinical study
protocol.
- Phase III and IV Outcomes Studies: Studies specifically
designed to evaluate health outcomes and conducted pre/post market
entry of bio-pharmaceutical products.
- Naturalistic Studies: Studies assessing the health outcomes
associated with one or more bio-pharmaceutical products or technologies
in a defined population with a specific medical condition under
actual or ordinary conditions of use.
Retrospective Health Outcomes Studies
- Claims Database Studies: Studies using medical and pharmacy
claims data to conduct a variety of post marketing assessments (e.g.
drug utilization rates, co-morbidity analysis, switch patterns,
and resource utilization).
- Medical Chart Review Studies: Studies involving the review
of patient medical charts in various settings of care to outline
the treatment course for a given medical condition and/or assess
patient outcomes and medical resource use associated with alternative
treatment options.
Outcomes Assessments Tools: Development of new outcomes assessments
tools (e.g. patient preference measures, patient satisfaction questionnaires
and QOL instruments) and validation of existing tools in previously
un-tested patient groups and languages.
Strategic and Implementation Plans: Plans highlighting health
outcomes strategies for bio-pharmaceutical products and proposing studies
essential to effective operationalization of those strategies.
Literature Reviews: Critical appraisals and syntheses of
pertinent health outcomes literature.
Competitor Reviews: In-depth analyses of strengths and weaknesses
of competitor health outcomes studies and promotional claims.
Opportunity Assessments: Assessment of the efficacy and safety
profiles of client and competitor products, disease epidemiology,
and market trends, and identification of the types of outcomes assessments
key to support market access.
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