As a freelance expert I provide customers with medically professional review of data from clinical trials according to ICH-GCP standards (so called, Medical Review). I support your project as needed, for example in time or manpower shortages. The information is checked for precision, completeness and validity (e.g., unreported adverse events). The aim of the review is that the study data reaches high quality (“clean”) and validity for its evaluation.

 I offer customers from pharmaceutical companies and CROs the following services:

• Coding Review (e.g. MedDRA, WHO-DD)
• Professional plausibility check of eCRFs with manual query creation and editing
• Medical review of data listings (line or aggregate listings) with manual query generation and handling
• Translation of medical texts from German to English
• Review of narratives