Selection of investigators
- extensive investigator pools - grown over years of clinical research - for
following therapeutic areas, for drug research and medical devices:
- allergology, angiology, cardiology, CNS, dermatology, diabetes, endocrinology,
ENT diseases, gastroenterology, gerontology, gynaecology, immunology, neurology, oncology,
ophthalmology, paediatrics, phlebology, pneumology, psychiatry, rheumatology, urology
- selection of new investigators by close contacts to universities and opinion
leaders
- access to investigators by information meetings, existing contacts with opinion
leaders and medical societies, mailings etc.
Setting up Study Sites
- recruitment of investigators and principal investigator
- pre-study visits and facility check acc. to ICH GCP (step 5)
- investigator meetings
- invitation, organization of location and travel, lectures in local language, GCP
training, information material
- initiation visits
- national regulatory affairs and Ethics Committee
application
Logistics
- material supply
- import/export and delivery of study material to investigational site
- organization of central lab service
- collection of biological samples
- installing of collaboration for external investigations (local labs, X-ray, CT,
MRT, other external diagnostics, etc.)