RISE can help with the design and execution of the non-clinical safety testing for vaccine from characterisation through formulation and safety studies to the approval by regulatory agencies. Toxicologists and immunologists can plan this path and highlight important considerations according to regulatory guidance and GLP.
Our experience tells us that the design of non-clinical safety studies for vaccines can look relatively different from case to case and that it is a good idea to think carefully consider a number of important aspects when planning for a GLP tox study for vaccines. Some of the reasons that can cause variations in the study design include:
An additional factor to consider lies in that vaccine often possess an innate capacity to induce tolerance for potential risks or side effects, as they often target a healthy population.
We at RISE can help with the strategic choices you need to make in moving your project from he non-clinical to the clinical phase and provide you a tailor-made strategy and study designs that suits your vaccine candidate's unique needs. Always in harmony with relevant regulatory guidelines (for example WHO 2005 and 2013 guidelines).
Our way of working is always adapted to the customer's needs. We offer:
In summary, with RISE as a partner, you get a well-thought-through toxicological evaluation to take your vaccine candidate as quickly and cost-effectively as possible to clinical studies. When approaching your project we are also able to act flexibly and swiftly in order to meet timelines and reduce the need for complex project management on your side.