U.S. biotech companies often have the need of conducting clinical trials in Europe.
Planning clinical studies in the European Union poses several operational and regulatory challenges, like finding suitable clinical sites in unknown countries, importing the drug product from the United States into Europe (or manufacturing the drug in the EU), or preparing trial applications for European regulatory authorities, among many others.
Therefore, U.S. sponsors, and particularly small biotech, will have a demanding and rugged road ahead before they can start recruiting patients in the Old Continent.
As Head of Clinical Operations in a CRO with solid expertise in European clinical trials, I focus on providing personalized guidance to Chief Executive, Scientific, Medical, and Clinical Operations Officers of U.S. biotech firms seeking to run phase 1 to 3 studies in the EU.
If you are planning a clinical trial in Europe, I can give you a hand in every step of the process (regardless of the therapeutic area), providing key recommendations and anticipating problems before they arise.
I provide all-in-one expert assistance (with the collaboration of recommended local specialists) in the following areas:
- Drug product import from the U.S. into the EU
- Active Pharmaceutical Ingredient (API) manufacturing in the EU
- Drug product manufacturing in the EU (including small batches for clinical trials)
- Analytical method development and validation for API and drug products
- Stability testing for API and drug products
- Batch release in Europe
- Drug labeling, storage, and distribution to European clinical sites
- Clinical trial submissions to regulatory authorities
- Full-service clinical trial management in any country of the EU
Interacting with multiple vendors for each of these services can be quite complicated and time consuming. Setting up and running a clinical trial is not easy, and in the EU the complexity grows when a multicenter study is to be conducted in different countries under distinct jurisdictions.
My task is to facilitate the whole process for you, understanding the unique needs of your drug and clinical study, and giving you a one-stop solution covering all the aspects of your project, from compound manufacturing to the publication of trial results.
Patricio Ledesma | EU Clinical Trial Consultant | pledesma@sofpromed.com | USA: +1 617 939 9497 | Europe: +34 607 939 266 | LinkedIn
