We perform studies throughout Europe, including Eastern Europe. These are in strict compliance with ICH/GCP guidelines, as well as with local regulations for specific countries.
You will receive committed and expert advice, be it for the whole project or parts of this. We will meet deadlines and cost specifications.
Our service for clinical studies:
• Conception of studies from Phases I to IV, drafting the study protocol and case report form
• Selection of suitable investigators and sites
• Obtaining the vote of the Ethics Committee: Preparation and submission of the documents to Ethics Committees
• Obtaining approval from the BfArM and/or institutions in other countries
• AE/SAE management
• Data management
• Data processing and statistics