Clinical Trials In The EU? Here’s What You Need To Know.
By Gavin Li
Director, Business Development, Asia-Pac
Moving your trial to the EU is no small task. Sponsors encounter challenges such as diverse regulatory agencies, varying approval parties, and different patient standards of care. Before considering a trial in the EU, you should know these five things about getting the Clinical Trial Application (CTA) and beyond.
Before diving into an EU-based trial, you should know these five things about getting a CTA in the EU:
IND (USA) and CTA (EU) have substantial differences. You will need only one IND per drug development program when applying in the US, but you must have one CTA for each study when running trials in the EU.
Europe is diverse. Despite efforts to harmonize procedures, there are many operational differences country-to-country across Europe. Even within one country, the timelines for getting approval can differ. Observations show that response speed depends on the indication and the quality of your submission package.
Double-check your feasibility. Run a good feasibility check where the study comparator or original drug or treatment is reimbursed. A good example is a study with biosimilars—while Western European countries will show little to no interest, many Eastern European countries frequently search for these studies.
Consider production and drug import locations. Depending on the production location, importation can be tricky. Any experienced, reliable partner should work with you to balance overhead in local drug depots or at sites versus the number of shipments.
The underestimated task—translations. With the diversity of European language networks, you need to plan and budget for translations. If you require back-translations, this can become even more burdensome. Make sure translation needs are planned.
Ready to learn more about planning and running clinical trials in the EU? We’re here to help you, whether you’re just getting started or your current plan just isn’t working. Please visit my page to schedule a meeting.
About the Author: With more than 12 years of industry experience, Gavin Li is Director, Business Development, Asia-Pac, at PSI CRO.
Clinical Trials In The EU? Here’s What You Need To Know.
By Gavin Li
Director, Business Development, Asia-Pac
Moving your trial to the EU is no small task. Sponsors encounter challenges such as diverse regulatory agencies, varying approval parties, and different patient standards of care. Before considering a trial in the EU, you should know these five things about getting the Clinical Trial Application (CTA) and beyond.
Before diving into an EU-based trial, you should know these five things about getting a CTA in the EU:
Ready to learn more about planning and running clinical trials in the EU? We’re here to help you, whether you’re just getting started or your current plan just isn’t working. Please visit my page to schedule a meeting.
About the Author: With more than 12 years of industry experience, Gavin Li is Director, Business Development, Asia-Pac, at PSI CRO.
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