How to Carry Out a Cancer Clinical Trial in Spain?

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

14 February, 2019

Cancer clinical trials are complex and sponsors should know in advance the critical aspects and local procedures that will be needed to undertake such large and demanding venture.

This knowledge becomes particularly important if the clinical study is conducted in a country with local procedures that may be unknown to the pharma or biotech company leading the project.

As explained in the article “Nine reasons to conduct an oncology clinical trial in Spain”, conducting clinical studies in Spain is a very interesting option.

We now explain what practical elements are needed to carry out a cancer trial in Spanish hospitals.

Considering that the sponsor has a new drug ready to test in cancer patients (i.e. preclinical development and compound manufacturing already completed), conducting a clinical trial involves the following aspects:

  1. Trial design
  2. Document writing
  3. Regulatory affairs
  4. Site selection and activation 
  5. Site management
  6. Data management
  7. Monitoring 
  8. Pharmacovigilance
  9. Logistics
  10. Project management

Most of these items are applicable to any clinical trial. Nevertheless, we have prepared a guide for sponsors specifically interested in developing oncology trials in Spain.

Would you like to read a detailed description of each of the elements listed above? You can Read our entire guide here:

This document provides highly valuable practical information concerning the requirements and local procedures involved in preparing and executing an oncology clinical trial in Spain.

If you have further questions, please write to info@sofpromed.com

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com