CRO services (B2B)

At Bioithas also act as a Contract Research Organization (CRO), carrying out clinical trials for third parties as an external service.

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We have worked in clinical trials with probiotics and with other nutritional supplements, and during the COVID-19 pandemic, we have participated in a clinical trial with medicinal products.

Since its inception, Bioithas’ main asset has been clinical trials 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, biotechnology and nutrition industry.

Find out more about us, our experience and the awards and accreditations we have received.

WE ARE BIOITHAS
Step by step

Project stages

At Bioithas, we handle all stages of the clinical project, from trial design to patient recruitment, including all relevant ethical evaluations:

01.

Clinical trial design and protocol writing, including an extensive literature search to update the state of the art in the study area, the selection of the most suitable variables to assess the results and the selection of eligibility criteria for participants.

02.

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 the Spanish Agency for Medicinal Products and Healthcare Products (AEMPS), if applicable).

03.

Selection of participating centres and researchers after a rigorous study of the options available to carry out the best possible work with a well-qualified team.

04.

Monitoring and control of the follow-up of the clinical trial to ensure that the protocol is followed without incident and that the project is as rigorous as possible.

05.

Digitisation and review of the data generated, as well as the creation of the raw database for subsequent full statistical analysis.

06.

Drafting of the final project report, including the results obtained.

The results of our trials often lead to clinical indications for the investigational product for the disease on which the clinical trial was conducted.

In addition, once the clinical trial is completed, we can undertake the writing of a scientific manuscript for publication in indexed journals.

If you have a probiotic or similar product, and you are interested in designing a robust clinical trial to demonstrate its effectiveness, please contact us.
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CRO Service Request

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    Our accreditations

    Innovative SME Seal
    Innovative Technology-Based Enterprise (EIBT) Seal