Vaccines
Solano Clinical Research has been conducting vaccine studies since 1993 focusing on Phase I - II safety and immunogenicity studies and Phase III efficacy studies. In the last 3 years we have completed 9 vaccine studies in healthy volunteers. There are several ongoing studies including multi-year studies. We work with a range of viral vaccine delivery systems including inoculation, plasmids, purified proteins and vaccines using sub-unit or live attenuated viruses. We are experienced with injections (intramuscular, subcutaneous) and transdermal systems. Our full-time Recruiter/Retention Specialist maintains a large database of healthy volunteers.
Solano Clinical Research has a track record in conducting multi-year vaccine studies. In 1998, we conducted a proof-of-principle study for one of the top ten pharmaceutical companies in the world. Based on our performance of rapid start-ups, enrollment, retention and low query rates, we were selected by the same sponsor to conduct studies in every phase of development through FDA approval in 2006.
All clinical research team members have completed the online training program: NIH Human Participants Protection Education for Research Teams. Our facility has a FWA number.
Experience and Research Interest
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We continue to expand our research experience. If your study indication is not listed above, please contact us and we will quickly let you know if we can help you.
Solano Clinical Research is Number 1 in Data Quality
Solano Clinical Research was one of the top enrollers of 5 sites participating in a Phase II immunogenicity and safety study in healthy adults. We enrolled 56 volunteers, 12% over the contracted enrollment. The study population was composed of males and females in the age range of 18 to 40 years. Some of the stringent study requirements included photographs of the subjects’ vaccination sites, processing of serum and storage at minus 70°C, and shipping samples on dry ice. To date, we have indications that our site is Number 1 for the quality of data, defined as having the cleanest data. Data was input electronically shortly after patient visits, well before the 72-hour requirement. We have the lowest number of queries to date. The sponsor was very pleased with Solano's performance and we were selected as the only site, of a total of 5 sites, to participate in the follow-on study.
Contact us if you have questions.
Clean Data
We are able to deliver clean data to clients because of GCP, ICH and FDA 21CFR compliance and well established standard operating procedures to ensure study success, low query rates and favorable audits. We frequently have the lowest number of queries per study among multiple sites.