Welcome.
Fresenius Kabi U.S. & Canada application portal for Investigator Initiated Trials (IITs)
Mission statement

Well-designed scientific research is the driving force for identifying better treatment for patients.
Fresenius Kabi may support independent studies to better understand the benefits and risks and application of clinical nutrition, intravenous fluids, generic injectables, biosimilars, infusion delivery solutions, and to address unmet medical needs.
Physicians, scientists, and other health care professionals, including PhD students and post-docs, from the U.S. and Canada are welcome to submit study proposals and apply for IIT sponsorship.
The sponsorship may be financial and/or include the provision of products.
About the program
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What we would consider
- Study applications from the U.S. and Canada with Fresenius Kabi products for clinical nutrition, intravenous fluid management, generic injectables, biosimilars, and infusion delivery solutions
- Studies exploring new indications
- Real world and observational studies
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What we do not consider
- Studies where the product is contraindicated
- Studies from third party firms exclusively that are without relevance to our products or strategic initiatives
- General educational and training activities are not included in the IIT evaluation program and are handled separately
- Studies founded or co-founded by direct competitors of Fresenius Kabi
- Studies where it appears that the risk:benefit ratio is too high
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Review criteria
Clinical trials researching clinical nutrition, intravenous fluid management, generic injectables, biosimilars, and infusion delivery solutions and preclinical in vitro or in vivo trials investigating the pharmacologic or toxicologic effects of a drug, clinical nutrition, an infusion delivery solution, or pharmaceutical ingredient can be submitted via this portal. Requests for monetary funding or (free) product provision require review under the IIT process set forth here.
Your submission will be reviewed by Fresenius Kabi based on its scientific relevance, alignment with our company or regional scientific objectives, investigator’s qualifications and expertise, and the following questions.
Scientific relevance
Does the study address a relevant scientific question? Will it have impact on clinical practice, close an important gap in scientific knowledge, or lead to novel concepts, therapies or indications?Scientific quality
Are the study design, the methods, and analyses adequately developed and appropriate for the scientific questions addressed by the study?Feasibility
Is the study team appropriately trained and does it have all relevant expertise? Are sufficient patients, materials, staff, or other resources available? Does the environment of the study (e.g., clinics, collaborations, lab) support the conduct of the study? Is the budget reasonable?
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Application process for clinical trials
The application process starts with submission of a concept proposal via this submission portal. This initial submission will only require some basic information about your intended study to keep your initial efforts low and allow a speedy evaluation.
If Fresenius Kabi is interested in the concept proposal, the investigator will be asked to submit a full study protocol. Fresenius Kabi will notify the investigator after the internal review(s) of the protocol.
Information required for the application process can be found here (pdf). In case of questions regarding your proposal, Fresenius Kabi will contact you via the contact information provided during the application process.
An overview of the application process is shown in the figure below:
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Application process for preclinical trials
The application process starts with submission of a concept proposal via this portal. After you have submitted your application, Fresenius Kabi will review your application and decide about supporting your study within approximately 90 working days.
Information required for the application process can be found here (pdf). In case of questions regarding your proposal, Fresenius Kabi will contact you via the contact information provided during the application process.
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Responsibilities of the investigator
The applicant and the study team must have the scientific, technical and operational skills, training (e.g. GCP, or GLP, Directive 2010/63/EU for animal studies, and any other national or international relevant regulations) and capacity to conduct the study. They need to make sure that the project complies with the principles of Good Research Practice and the Declaration of Helsinki for clinical trials.
The medical/academic institution/HCO is the sponsor of the trial and responsible for the trial conduct including study protocol, safety reporting, analysis of the results, final study report, and administrative work, e.g., patient insurance for clinical studies, submission, and/or reporting to EC/IRB and health authorities, obtaining of relevant (ethical/operational) licenses, etc.
In case Fresenius Kabi supports the IIT or preclinical research project by entering into a contract with a medical/academic institution/HCO, according to such contract, the investigators will be required to provide quarterly study updates for Fresenius Kabi to inform on study proceedings, congress contributions and manuscript drafts in relation to the study. The investigators will further be required to state in any scientific publication, abstract and/or presentation that the study was supported by Fresenius Kabi.