Vaccine typically containing an agent provides active acquired immunity to a particular disease. Vaccine development is a long, complex process. The emphasis of vaccine clinical trials is safety as well as efficacy. CD BioSciences has full-range of services and expertise to help customers smoothly initiate and complete critical stages of clinical trials that meet the appropriate regulatory requirements.
Clinical Services for Vaccine Program
The clinical studies include 4 phases to assess the safety of candidate vaccine, determine the type and extent of immune response that the vaccine provokes, quantitatively measure the specific capacity of candidate vaccine to achieve a expected biological effect, study the candidate vaccine's immunogenicity, proposed doses, schedule of immunizations, and method of delivery, and test vaccine efficacy.
- Advanced cold chain logistics and vaccine storage can meet the logistical challenges during clinical trials.
- Provide detailed protocol including the background, principle and goals of the clinical trial. The methodology and organization, statistical considerations, reporting procedure of adverse events, and the conditions under which it is to be performed and managed are also included in this protocol.
- The appropriate setting of high incidence of the infectious disease will be selected to conduct the clinical trials in order to provide a good readout of the end point.
- Define the specific inclusion and exclusion criteria for each phase of the clinical trial and enroll subjects adhere to the defined criteria.
- Intensive investigations including evaluation of any clinical signs of infection will be conducted on volunteers in closely monitored clinical settings. Adverse events following vaccination will be well documented. Beside that, after the finish of clinical trial, continuous safety monitoring of trial participants for a defined is also an important part of our service.
- Provide regular inspection on the site of clinical trial in order to verify that all the procedures adhere to good clinical practice.
- Standardized approaches of data collection, collation, analysis and reporting ensure the comparability of safety data within and across clinical trials.
- Our in-depth experiences in immunology and anti-infective researches make us a perfect partner to support your vaccine development.
- Our tailored solutions include assay development, project monitoring and data management to meet you complex and unique needs across the entire vaccine development life cycle.
CD BioSciences is dedicated to providing full range of clinical trials services. We adhere to the integrity and professionalism, to win the trust and cooperation of customers. Please don't hesitate to contact us for further information about our service.
1. World Health Organization. "WHO guidelines on nonclinical evaluation of vaccines." WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization (2005).