There is great opportunity for US companies to run clinical trials in the EU, but it can be challenging to navigate the unfamiliar and complex approval processes. At Siron Clinical, we have extensive experience of this process spanning 120 trials over 20 years.
In a new eBook, launched on 26 August 2020, we share our insights and knowledge, helping US companies successfully start EU trials. You can download it free on the Siron Clinical website.
Navigating the EU trial application process
The 27 countries of the European Union provide broad scope to trial vaccines and treatments – so much so that in July 2020, there were more than 37,600 trials registered in the EU Clinical Trials Register. Many of these are run alongside US trials, but the process looks different.
In the eBook, we outline where and how to get started, with details specifically aimed at supporting US companies moving into the EU trials space.
For US companies, the first step is to understand the differences between the more familiar US process and what is found throughout the EU. Understanding and taking into account details such as variations in responsibilities and timelines can be helpful here.
It is also critical to understand the details of the regulations in place in the EU, which are different to those in the US. In particular, there are EU-level regulations to take into consideration, as well as national regulations for each Member State. Depending on where you plan to run a trial, you will need to look into different laws and ensure the planning and execution are compliant.
There is a chapter in the eBook outlining the differences between EU and US processes, and another that delves into the relevant EU-level legislation to consider.
A step-by-step guide to getting started
Experience is a key factor in successful EU trials. If you have not yet conducted a trial in the EU, you can benefit from others’ experience – we aim to share some of the experience our clients benefit from in the eBook.
You can increase your chances of getting approval with a solid strategy and by preparing your application ahead of submission; planning is one area where experience matters. As you plan your trial, it is a good idea to consider how you could benefit from working with an experienced Contract Research Organization (CRO) like Siron Clinical, who can guide you through the complex application process and ensure your EU trial runs smoothly.
In the eBook, we outline the steps to prepare for your trial application, covering:
- Timeline
- Planning
- Strategy
- Preparation
- Submission
- Getting started
Guidance you can put into practice
At Siron Clinical, we have more than 20 years’ experience working on clinical trials in the EU and the USA, so we understand the challenges involved – and we know how to overcome them.
In the eBook, we provide practical guidance that will help you go through the application and approvals processes for running an EU trial. You can now download the eBook free from the Siron Clinical website.
If you need further support – not just for the application and approval processes, but also in project management, clinical monitoring and quality assurance – Siron Clinical is here to help.
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