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Designing a trial to meet the minimum FDA requirements is not sufficient to ensure product success. Health Advances combines an understanding of regulatory
requirements and processes with a critical market perspective to formulate a practical, robust clinical strategy that will change the treatment paradigm and
drive adoption. Major elements of our clinical trial strategy and benchmarking practice include:
- Documenting clinical and scientific benchmarks of product performance and supporting data for
competitors and recent product filings in the related area(s).
- Identifying new or proposed regulatory guidelines or rulings that will impact expectations
for future trials.
- Identifying the key users and/or purchases of the product and understanding how they will
evaluate the new product, including the level of performance along several dimensions such as
safety, efficacy, ease of use, etc., that will be required to move them to change current practices.
- Evaluating various trial design options and prioritizing the options by comparing the likely duration
and cost of each, as well as the probability of success given available product and market information and
the likelihood that the results, if successful, will be sufficient to gain adoption and to what degree
penetration is likely to occur with various claims possibilities.
Health Advances is focused on helping our clients determine the optimal clinical trial strategy and is not
biased in any way by the implications for follow-up trial management work, since we are not a CRO. If a small
and fast trial is the best first step in the overall development strategy, then that will be the recommendation.
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 learn more about our work in clinical trial strategy and benchmarking. |
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