Clinical Development

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:

  • Briefing documents for Scientific Advices

  • Clinical Trial Authorizations/Investigational New Drug Applications

  • CRO selection and management

  • Focus on

  • Investigator Brochures

  • Clinical Study Protocols/ Reports

  • Clinical Summaries and Overviews

  • Summary of Product Characteristics

  • Patient Information Leaflets

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