Clinical Research

Clinical Research Consulting

Beyond conducting full service clinical studies, we offer a broad variety of customized consulting services by highly experienced subject matter experts. This is particularly relevant for medical device clients, as evaluation by an independent evaluator is required per MEDDEV 2.7/1 rev. 4.

MAIN AREAS:

  • Development/review of clinical development plan/study documents
  • Support with selection/oversight of trial execution partner
  • Study setup support
  • Training

DEVELOPMENT/REVIEW OF KEY STUDY DOCUMENTS

  • Study synopsis/protocol – refined for evaluation of effects of natural products
  • Statistical analysis plan
  • Statistical analysis report
  • Clinical study report
  • In line with study specific requirements (e.g. ICH guidelines, ISO norm, EFSA guidances)

Get in touch with us

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