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Study Design

We work diligently with our clients to produce a study design meeting all regulatory, commercial and technical needs. Our staff also assists with negotiations on the classification of your device. We identify labelling claims best suited to your objectives and write bibliographic reviews that may in the end allow approval to market the device without the need for clinical data. In short, we help clients optimize the design of the clinical research program. We also ensure that there is adequate statistical input to the design to justify the number of patients and ensure the data generated are going to be adequately powered to meet the client’s needs.

In some cases, the commercial objectives for a clinical research program are not immediately obvious. Pleiad works with the client to perform a market assessment allowing the target market to be identified, quantified and qualified. We undertake desk research and then interview key opinion leaders as part of the market assessment. We also organize focus groups and advisory boards, providing short and long term technical, clinical and commercial support for senior management.