QPS, a global contract research organization (CRO) focused on bioanalytics and clinical trials, is honored to have collaborated with Medigen Vaccine Biologics Corporation to complete toxicology studies necessary for the development of a COVID-19 vaccine.
Researchers at the Center of Toxicology and Preclinical Sciences (CTPS) at QPS Taiwan completed the studies swiftly to accelerate the development of the vaccine, which has just been approved by the Taiwan Food and Drug Administration (TFDA) for Emergency Use Authorization (EUA) in Taiwan. Medigen Vaccine Biologics Corporation also successfully secured a first-of-its-kind government grant for the clinical trial of the novel vaccine, which helped expedite the vaccine development.
CTPS at QPS Taiwan was the primary testing facility for the toxicity study of the novel vaccine. The researchers accepted the first clinical cases in October 2020 and completed the studies in just a few months. The team met all scientific objectives, analyzed all endpoints, and reported all outcomes as scheduled. "We recognized the urgency of the global demand for a 'just-in-time' solution to join the fight against COVID-19 and made available the most expedient study schedule to our client for the kick-off," said Charlene Chen, Deputy General Manager and Head of CTPS at QPS Taiwan.
The team of researchers at CTPS at QPS Taiwan listened to the needs of its partner, delivering prompt and flexible study execution, frequent and thorough reporting, and on-the-fly responses to inquiries and requests. Keeping in mind optimal toxicity study designs and addressing specific requirements and concerns of the regulatory review, the researchers generated weekly updates of the ongoing study. These updates kept the client and the regulatory review abreast of the latest study advancements and outcomes. Despite the rapid pace of research, the quality of these interim reports remained consistent with the team's usual high standard for study reporting.
QPS Taiwan was able to provide further support to the vaccine development effort through the QPS Unitix division. QPS Unitix deployed a legion of study nurses across four medical centers to recruit over 50 percent of the eligible subjects required for the trial in just two months.
"QPS has been an integral member of the local community in Taiwan for over 20 years, providing support to the pharma and biotech industries," Chen said, "and we are committed to responding to the needs of both the community and our clients." With the support of QPS Taiwan, Medigen Vaccine Biologics Corp has delivered a new tool in the arsenal to fight against the COVID-19 pandemic.
ABOUT QPS HOLDINGS, LLC
QPS is a global contract research organization (CRO) providing discovery, preclinical, and clinical drug development services since 1995. The company accelerates pharmaceutical breakthroughs across the globe by delivering custom-built research services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction, and turnkey laboratories and facilities. QPS has CLIA-certified and GLP-compliant laboratories ready to fast-track your novel coronavirus and COVID-19 RT-qPCR/QPCR, serological assays, and vaccine development programs.
For more information, visit www.qps.com