What regulations do I have to follow for drug studies?

The most important regulations for clinical trials

Declaration of Helsinki:

This declaration of the World Medical Association formulates ethical principles for medical research involving humans and serves as an ethical guideline for clinical trials.

Good Clinical Practice (GCP):

GCP forms the foundation for clinical trials by ensuring the protection of participants’ rights, the transparent documentation of all processes and the achievement of scientifically valid, reproducible results.

EU Regulation 536/2014:

This regulation creates a harmonized approval procedure within the EU. It facilitates the conduct of multinational studies and ensures greater transparency by requiring study results to be made publicly available.

Medicinal Products Act (AMG):

The AMG regulates the approval and conduct of clinical trials. Coordination with ethics committees and ensuring patient safety are particularly important here.

General Data Protection Regulation (GDPR):

The protection of personal data is of the highest priority. The GDPR ensures that participant data is processed securely and used only for the specified purposes.

Specific local requirements:

Depending on the region, additional country-specific regulations may apply that must be observed.

Common compliance challenges

Compliance with all these regulations is complex and requires not only in-depth knowledge but also careful planning and control. Many companies encounter difficulties because:

Lack of overview: Which regulations apply to my specific study?

Resources are limited: Who is responsible for compliance with the regulations?

Details are overlooked: Even small mistakes can lead to expensive delays or legal consequences.

These challenges can seem overwhelming, but with the right support they can be overcome.

How we can help you

• Consulting and training: We bring you and your team up to date with the latest legal requirements.
• Review of your study documents: We review your study plan and other documents for compliance.
• Approval procedures: We coordinate the submission to ethics committees and authorities.
• Continuous monitoring: We monitor your study to ensure compliance with all regulations.

Your advantage: Safe, efficient and compliant

With our support, you save time and avoid costly mistakes. We help you concentrate on the essentials – the success of your clinical study.