Services 2017-05-16T17:10:13+00:00

Services

Our strenghts lies in our expertise in developing sophisticated study concepts for natural products, and we can help you reveal the biological potential of your products. Compared to synthetic drugs, natural products are often characterized by small effect sizes and by a delayed onset of the effects. The selection of the study population, the assessment parameters (incl. documentation), the course of study, and the analytical methods have to address these particularities.

a&r services include:

Project Management

  • Planning and concept development of clinical trials
  • Generation / compilation of relevant / essential documents
  • Handling of investigational product (incl. randomisation / labeling / blinding)
  • Submissions to authorities and ethic committees
  • Recruitment of study sites (feasibility)
  • Study conduct and coordination

Data Management / Statistics

  • Sample size calculation
  • Planning and concept development of the statistical analysis
  • Data management
  • Statistical analysis of study data

Monitoring

  • Identification and assessment of adequate study sites
  • Preparation and conduct of initiation visits
  • Training of study site personnel
  • Preparation and conduct of routine monitoring visits
  • Preparation and conduct of close-out visits

Associated study site

  • Recruitment of subjects (incl. subject database)
  • Efficient and timely study conduct
  • Study-specific special assessments

Additional services

In addition, we can support you in the generation of additional scientific evidence for your product in the area of pre-clinical studies:

  • In-vitro / in-vivo studies
  • Planning / design of in-vitro and in-vivo studies
  • Selection of accredited laboratories (worldwide)
  • Study conduct and data analysis
  • Writing of study reports and publications

Medical writing

  • Generation of clinical study protocols
  • Writing of clinical study reports
  • Writing of publications (incl. meta analysis)