SERVICES
We conduct clinical trials at a single research center to evaluate the safety, tolerability, efficacy, and immunogenicity of vaccines in healthy individuals. Our experienced team and state-of-the-art facilities ensure that each study is conducted with the highest standards of quality and compliance.
Experience efficiency and cost-effectiveness with the expertise of Convex Research. We collaborate with our partners to investigate the safety and effectiveness of their vaccine products before they submit their documentation for regulatory authority approval.
During Phase I, we introduce the vaccine candidate to assess its safety in healthy subjects. Participants are randomly assigned to receive either the vaccine candidate or a placebo. Our primary objectives are to detect any adverse events and demonstrate evidence of an immune response.
To minimize the likelihood of serious adverse effects, we employ an escalation study design with a small group of healthy volunteers. The initial subgroup receives the lowest expected dose necessary to elicit an immune response. Subsequent subgroups are administered increasing doses until the tolerability requirement is met. We believe that escalation trial designs are ideal for mitigating the risks of serious adverse events.
In Phase II, we have the capacity to include hundreds of healthy volunteers from the target population for the vaccine. This allows us to assess reactions in a more diverse set of individuals and explore different dosing schedules.
The vaccination schedule varies based on the specific characteristics of the vaccine. This phase provides crucial data on the immune response across different demographic groups and helps optimize the dosing regimen for subsequent trials.
During Phase III, we continue to monitor toxicity, immunogenicity, and safety on a larger scale. We collaborate with our partners to investigate the safety and effectiveness of their vaccine products before they submit their documentation for regulatory authority approval.
This phase provides comprehensive data on vaccine performance in real-world conditions and generates the evidence required for regulatory submissions and market authorization.
Safety & Efficacy Focus
Immunogenicity Assessment
Fast Recruitment
Regulatory Expertise
If you have any inquiries regarding clinical trials on vaccines or if you would like to discuss your upcoming project and how Convex can contribute to its successful execution, please do not hesitate to contact us. You can reach us at info@convex.bg, and we would be delighted to respond to your inquiries and provide you with the necessary information.
