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Nutritional CRO

Nutritional CRO

Over 25 years of expertise and international experience in nutritional and clinical issues relating to bioactive ingredients

We are in vivo experts for food. Our interdisciplinary team offers customer-specific solutions for study design and implementation at our in-house study site or in collaboration with external institutions. 

To ensure the highest quality standards, our in-house QM system is certified in accordance with ISO 9001. All studies are conducted in accordance with ICH-GCP guidelines. An electronic data capture (EDC) system with complete documentation (full audit trail) has been implemented for data collection.

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DELIVER ON WHAT YOUR PRODUCT PROMISES

The aim of our studies is to validate concepts, prove health-related effects to underpin products and scientifically substantiate health claims for market communication.

We offer:

  • Development of meaningful concepts to substantiate product positioning
  • Planning, organisation and implementation of clinical studies
  • In-house study site with adjoining test laboratory
  • Implementation in accordance with ICH-GCP documentation with EDC system with full audit trail
  • Broad spectrum of indication areas
  • Publication of scientific results
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Responsibility towards the customer and security in marketing

We are the central driving forces behind our customers' product development. This requirement is all the more important when it comes to nutrition. That is why we offer our customers our support, based on more than 25 years of experience. I am a nutritionist (University of Hohenheim) and at Biotesys GmbH I lead a highly motivated study team from the fields of nutritional science, biochemistry and physiotherapy as well as study nurses. These complementary competences are necessary in order to understand the diverse problems in the fields of nutrition, cosmetics and related areas and to develop viable solutions. On this basis, we work with you to develop an optimal study design, prepare all the necessary documents, take care of communication with the ethics committee or the BfArM if necessary, conduct the study via our study site, evaluate the study results and prepare a report."

 

Christiane Schön, Head of Department Nutritional CRO

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Our range of services

We support your clinical trial from planning to implementation to evaluation – with our own study site, experienced team, fast routes, high quality and transparent processes.

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Our areas of application

For over 25 years, we have been testing the effects of functional ingredients in clinical studies – from bioavailability and gut health to the immune system, weight management, and cardiometabolic health.

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Our product groups

In vivo studies for food, cosmetics & oral hygiene, and medical devices – regulatory compliance with LFGB, EU Cosmetics Regulation, and MDR.

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Our methods

Overview of established objective and subjective methods for clinical studies in nutrition research – from endothelial function, BIA, and 24-hour blood pressure to cognitive tests, GI parameters, and validated questionnaires.

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Our quality standards

Biotesys guarantees reliable study quality from conception to implementation at its in-house study site: clearly defined study objectives, customer-specific designs, suitable endpoints and biomarkers as well as adherence to schedules and costs.

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