Vaccines
Vaccines are biopharmacy that provide positive acquired immunity to specific infectious diseases. Vaccines usually contain active ingredients that resemble disease-causing microorganisms and are often made in a weakened or dead form from microorganisms, their toxins, or one of their surface proteins. Drugs stimulate the body’s immune system to recognize and destroy the drug as a threat, as well as to recognize and destroy microorganisms associated with the drug that may be encountered in the future. Vaccines can be prophylactic (to prevent or mitigate the effects of future infections by natural or “wild” pathogens) or therapeutic (to combat established diseases such as cancer). Some vaccines provide complete bactericidal immunity and completely prevent infection.
Information about Clinical Trials
Onyx Clinical’s Vaccine teams are experts in the scientific approach, standard of care, growing regulatory requirements, and operational factors required to bring medications and devices to market that treat or prevent vaccine issues. Our significant experience in vaccine studies, together with our proven track record of success in the vaccine CRO market, means that we can adapt to each vaccine trial’s specific demands.
In order to ensure success, we help our clients:
- Plan and conduct vaccine studies for drug/device and skin care safety in an efficient and effective manner.
- Conduct big vaccine endpoint trials efficiently while adhering to stringent safety guidelines.
- Integrate vaccine trials without difficulty.
Crucial Vaccine Information
Deep and Broad Vaccine Experience
We’ve done hundreds of Phase I-IV vaccine trials for pharmaceuticals and medical devices since our establishment in 2017.
We have learned the following from these studies:
- Involved patients in nearly 50 different countries
- Contributed to countless vaccine NDAs
- Pioneered many of the preventative vaccine drugs and devices introduced in the past 15 years
- Conducted studies including acute care setting, drug/device combination, large outcome, thorough QT, as well as managing Clinical Endpoint Committees (CEC) and adjudication processes for numerous studies
