European ethical oversight and regulatory bodies are nowadays very intricate, and clinical trial approvals therefore require bespoke documents as well as people who know how to manage the application process. Our team interacts not only with the international, national and local regulatory authorities, but also with ethics committees and institutional review boards. This type of coordinated effort is necessary for fulfilling the regulatory requirements to conduct your clinical trial.
At FGK we are always up to date with the most recent regulatory requirements. We efficiently navigate your project through the complex meshwork of regulations and guidelines (many of which are de facto regulations if you wish to avoid delay) and ensure compliance with the international standards, e.g. Good Clinical Practice (GCP) by the International Conference on Harmonization (ICH).
Moreover, having created your successful clinical trial application, FGK regulatory professionals support your project throughout should the need arise, whether it involves amendments, notifications, periodic reporting or regulatory advice.