Expedit Nodum Ltd.

is a contract research organization CRO dealing especially with food and nutrition related studies, projects’ elaboration and implementation with special regard to human clinical studies of foodstuffs of high added value. Expedit Nodum company team has got wide experience in organizing phase I, II. and III. clinical trials in pharma industry and also in food related and supplementation projects as well. Our clinicians, nutritional scientist, dieticians and study coordinators will take care of regulatory affairs, investigational product logistics, volunteer recruitment and enrolment to the pilot study, furthermore will take care of quality assurance and adequate trial performance according national legislation, FDA, EMEA and GCP guidelines at the selected site in Hungary or abroad.

As a unique CRO in Hungary takes care and has got comprehensive knowledge not only on human clinical trial organization, but ont he planing, technology, market place and consumer judgement of certain foodstuff or food supplement.

Expedit Nodum has been participating in several food science related innovation projects and calls as coordinator, furthermore the scientists of the company were taking part in the development and design of several functional foodstuffs.

The company constitutes a bridge between food science and medical science , as makes the contribution of such human clinical experts with knowledge on food science indispensable. The major goal is to provide convincing proof on the real physiological impacts of the test food product.

Services:

What makes our service so complex and why is it worth it to you? Watch our introductory animated movie and you will have no doubts:

The activities of our company extend to expert advising for producers and entreprenours on food and supplement design, as well as tailoring research development strategies concerning food science and nutrition.

  1. Professional advisory activity on field of food industryfood technologynutritional science and human clinical trials
  2. Strategy developement
  3. Giving hand on broadening of product range of foodindustrial companies
  4. Design of functional foodstaffs
  5. Call and tender monitoringcall preparation and coordination in field of food- or nutrition-science
  6. Regulatory legislation advisory activity (OGYÉI, EFSA, „novel food legislation”, „Health claims”)

Expedit Nodum possesses well-established contacts with healthcare professionals at investigational sites in a wide range of highly specialized therapeutic areas, what makes the company highly suitable for planing, managing regulatory affairs, organising, evaluating and implementation of human clinical trials.

  1. Protocol planing and study design
  2. Medical indication determination
  3. Trial population determination, criteria
  4. Regulatory and ethical submission procedure management
  5. Investigational site feasibility
  6. Quest of further feasible sites
  7. Human clinical trial organization
  8. Investigational product determination, production management
  9. Placebo design
  10. Investigational product logistics
  11. Organization of special laboratory examinations
  12. Statistical evaluation of the results
  13. Trial report preparation

Professional activities of Expedit Nodum cover also the fields of development and operation of specific in vitro digestion model systems for the proper estimation of the possible physiological effects of newly developed functional foodstuffs and bioactive components.

  1. Development of in vitro digestion modelling systems as a pre-selective step of the clinical trials
  2. 4 intestinal tract modelling opportunity
  3. Different age-specific model development
  4. Evaluation of prebiotic index from foodstaffs or food ingredients
  5. Antioxidant amount and capacity evaluation from foodstaffs or food ingredients

The Expedit Nodum’s activities cover the glycemic index measurement with a well-established, standardized methodology giving dependable glycemic index value.

  1. At least 10 volunteers included
  2. Appropriate repeats in the experimental and control measurements
  3. Accurate blood glucose measurement
  4. Blood glucose measurement 7 times per test day
  5. Adequate amount of control glucose solution
  6. Appropriate statistical evaluation
  7. Quick transmission of results

The Expedit Nodum plans new, innovative and creative functional foodstuff prototypes according to the conception of producers and entrepreneurs ensuring the technological, nutritional and regulatory conformance.

  1. Complex, interdisciplinary, professional approach
  2. The prototype meets the requirements of legalisation, prescribed rules and regulations, specified standards
  3. Sensory testing and evaluation of the different food prototypes
  4. Food label planning including the nutritional and health claims on the functional foodstuff
  5. Exploration of the regulatory and procurement opportunities of special food compartments
  6. Adequate efficiency tests according to the sponsor requirements and demands