Guidance documents accessible from this page represent the Agency's current thinking on good clinical practice (GCP) and the conduct of clinical trials.
The new Clinical Trials legislation, which was adopted on 16 April 2014 and entered into force on 16 June 2014, has taken the legal form of a Regulation. This will ensure that the rules for conducting clinical trials are identical throughout the EU
Full-service Clinical Trials for registration
Insourcing/outsourcing CRA/CRC
Medical Document Translation Services
Regulatory management
Clinical Trial feasibility & site selection
Clinical site management & Monitoring
Other drug and vaccine related activities
Protocol and Informed Consent Form Development
Clinical Trial Quality Assurance
Data Management and Analysis
Quantitative Clinical Development Services
Clinical Project management