BeeSafe performs bee field studies for the veterinary sector, especially clinical and dose confirmation studies in the registration process of Veterinary Medicinal Products (VMP) for bees. In addition, feeding studies for supplements for honey bee nutrition are possible.
Clinical and dose confirmation studies
According to the guideline for VMPs controlling Varroa destructor, studies to prove the efficacy and safety for bee colonies are necessary for the registration of varroa treatments. These clinical studies are the core of the registration process. BeeSafe performs these studies in collaboration with experienced technical personnel to ensure the high quality of the studies.
Though following the guideline, each study needs a specific planning according to the properties of the VMP. If you already did a roadmap session with BeeSafe, this will already be clear. Otherwise, we begin with a planning session for clarifying all the details on the timing of the treatment, the posology, and other parameters. This is necessary to make sure that the study represents a practical case under field conditions. And, by this, save you time and money by getting realistic results.
Both clinical and dose confirmation studies need the final formulation of the product. If you’re still in the development phase of the product, field studies covering the development of the formulation, the posology, etc. are also possible. Contact me to know more!
Feeding studies
Feed supplements for honey bees are usually nutritional additives, like protein supplements or vitamins. They have to show their beneficial effect on colony health and development. Honey bees are food producing animals. Therefore, the safety for any hive products used for food (honey, wax) has to be proven.
BeeSafe performs the necessary feeding studies according to the current guidelines.
Terms and conditions
Each study will receive a tailored quote to meet the requirements of the product. Only services mentioned in the quote are part of the project. Any additional services that may become necessary during the study (additional experimental groups, samplings, assessments, etc.) or changes in the study design will get an additional and separate quote. Consultancy is NOT part of field studies. This includes any work on the dossier, export reports, or answering questions during the authorisation procedure. If you need help with this, BeeSafe will set up a separate consultancy project.
I value the time of my clients as well as mine. Therefore, any changes in report dates or other timelines need previous discussion, mutual consent and respecting the necessities of the study. Anticipations or new elements of the study not previously agreed upon are only possible if they do not interact with the interest of other projects. The costs of the study will be adjusted accordingly with an urgency fee.
BeeSafe can plan out studies only based on the information provided by the sponsor. Studies have the scope to deliver a solid foundation for the risk-benefit analysis during the registration process. So, to design proper studies, that will provide the necessary data, BeeSafe needs all information, including potential issues. If any relevant information is missing, no responbility is taken by BeeSafe.
The test product, as well as any reference or control products must be provided by the sponsor. If BeeSafe has to provide any products or materials after initiation of the study, the cost of the material as well as the time necessary for the organisation will be invoiced.