


Clinical Trials
I help you design and implement your clinical development program or single most important pivotal trial – combining scientific excellence with healthy pragmatism and always dedicated to achieve your key objectives with high quality on time and on budget.
Mentoring and consulting services include
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Determination of the regulatory framework that specifcally applies to your innovation and intended use. Clarification whether clinical trials are even necessary.
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Setup of clinical trials answering your research questions, supporting your value proposition, and strengthening your standing with regulators, payers and healthcare providers.
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Scientific, regulatory and operational design of your clinical trial(s) up to the completion of a clinical trial synopsis.
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Selection and supervision of partners and service providers (CRO) to ensure that your study is implemented with a high quality on time and on budget.
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Scientific support for the evaluation and interpretation of trial data.
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Presentation of trial outcomes to your stakeholder audiences such as funders and supporters, regulatory authorities, payers, healthcare providers, patient associations and scientific societies.
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Publication of your clinical trials in peer-reviewed journals.