Development of clinical strategies, review of documents (IB, study protocol, study report) to assure the correct performance of the study and the proper reporting of the results obtained.
Target clients: pharmaceutical companies, especially small and medium sized ones developing e.g. generic drugs which need support during different phases, but especially in Phase I, in the clinical development of their products.
I am supporting your clinical development by providing the following services:
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Briefing documents for Scientific Advices
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Clinical Trial Authorizations/Investigational New Drug Applications
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CRO selection and management
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Focus on
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Investigator Brochures
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Clinical Study Protocols/ Reports
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Clinical Summaries and Overviews
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Summary of Product Characteristics
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Patient Information Leaflets