We have worked on clinical studies with probiotics , with other nutritional supplements and, during the COVID-19 pandemic, we have participated in a clinical trial with drugs .
Bioithas' main asset since its inception has been clinical studies in humans, and our experience in conducting our own clinical trials. This background has allowed us to put our knowledge and experience in this field at the service of other companies in the pharmaceutical, biotechnological and nutritional industry .
Find out more about us, our experience and the awards and accreditations we have been awarded.
Step by Step
At Bioithas, we carry out all stages of the clinical project , from trial design to patient recruitment, going through all relevant ethical assessments:
Design of the clinical trial and writing of the protocols , including an extensive bibliographic search to update the state of the art of the study area, the selection of the most suitable variables to evaluate the results and the eligibility criteria of the participants.
Drafting of all the documentation attached to the clinical trial, as well as the management of the evaluation process by the competent authorities (research ethics committees and AEMPS, where appropriate).
Selection of the participating centers and researchers after a rigorous study of the options available to carry out the best possible work with a well-qualified team.
Monitoring and control of the follow-up of the clinical trial to confirm that the protocol is followed without incident and that the project is as rigorous as possible.
Digitization and review of the generated data , as well as the creation of the raw data base for the subsequent complete statistical analysis .
Drafting of the final project report , including the results obtained.
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