Clinical Trial Services

CLINSTEP can help you

• Define a regulatory strategy to get your clinical trials started
• Submit your study to the Ethics Committees to obtain EC approval
• Submit your CTA to the EMEA via the EudraCT Database
• Submit your clinical trial to the Competent Authority for approval
• Site identification and Investigator selection
• Trial Master File Compilation
• IMPD Compilation
• Investigator's Brochure Compilation
• Site Management
• Clinical Project Management
• Stay compliant with GCP requirements
• Review your study documentation
• Get your additional local submissions through, such as local pharmacy approvals etc.
• Get a Qualified Person or a Legal Representative as it is required for drug clinical trials in Europe
• Get your study documentation translated in any local language fast.

In short CLINSTEP can be your outsourced clinical trial arm. Move now. Contact us for a free quote.