At CenExel Clinical Research, our top priorities are the safety and health of our patients and employees. For our Centers of Excellence to provide the highest quality of clinical research, we established and maintain a COVID-19 Task Force with representatives from every Center. The Task Force is charged with continuous monitoring of the pandemic and providing guidance and communication.
Our clinical operations continue, and we have implemented the following additional safety measures:
Enhanced screening of everyone entering any of our facilities before they are admitted into our offices or clinical areas
Reinforced internal communication regarding the COVID-19 situation, CDC and SHRM recommendations, digital team meetings, and the importance of using sick leave for anyone who has signs, symptoms, or recent exposure to someone with suspected or diagnosed COVID-19
Additional cleaning and disinfecting materials provided through our clinic and office areas
Cross-training and preparations for contingency plans if key staff need to stay home
We will continue to monitor the current situation, coordinate with the proper authorities, and update our policies and procedures as needed to ensure the safety of our patients and employees.
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Research Centers of America (RCA), Broward County’s largest independent research site, is currently conducting COVID-19 vaccine trials, implemented under Operation Warp Speed (OWS). RCA is recruiting volunteers to participate in these clinical trials, working with the Federal Government and many major Pharmaceutical Companies, which developed a vaccine to potentially prevent COVID-19.
Dr. Howard Schwartz, Chief Medical Officer at Research Centers of America, met with several news media channels and was also part of a roundtable discussion with Vice President Mike Pence, school leaders and members of the Miller School of Medicine, along with several other researchers working to end the ongoing battle against the Coronavirus.
The first trial will be for Moderna, which is expected to enroll approximately 30,000 participants in the United States. RCA will recruit between 300 to 500 participants for Moderna’s trial alone.
Moderna (July 27th Press Release):
“The Phase 3 study protocol follows the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies. The randomized, placebo-controlled trial is expected to include approximately 30,000 participants in the United States, testing an mRNA-1273 dosage of 100 µg. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2 regardless of symptomology. SARS-CoV-2 is the virus that causes COVID-19.
The primary efficacy analysis of the Phase 3 study will be an event-driven analysis, based on the number of participants with symptomatic COVID-19 disease. To ensure the ongoing safety and monitoring of the participants in the trial, data will be reviewed by an independent Data and Safety Monitoring Board organized by NIAID throughout the study. The clinicaltrials.gov identifier is NCT04470427.”
Research Centers of America is honored and excited to begin this process and to be a part of the fight against the Coronavirus, which has dramatically affected the entire world we live in. RCA is using every possible channel and means at their disposal to inform and involve the community in this important mission and study.
Dr. Howard Schwartz, Chief Medical Officer at Research Centers of America, met with several news media channels and was also part of a roundtable discussion with Vice President Mike Pence, school leaders and members of the Miller School of Medicine, along with several other researchers working to end the ongoing battle against the Coronavirus.
“Today is a day of hope,” Pence concluded. “Today is a day of promise. If all of us continue to do all we can, we’re going to reach the day when we put this coronavirus behind us.”
About RCA:
RCA is an independently owned and operated research company. RCA specializes in conducting Phase I-IV vaccines and CNS trials for pharmaceutical and biotech companies. At RCA we are committed to delivering solid science and applying strict adherence to GCP/ICH, as well as training according to FDA Code of Federal Regulations. Committed to the integrity and quality of our work, RCA delivers accurate results and aims to exceed our goals in medical advancement.
RCA team members have been leaders in the clinical trial industry for the past 25 years, successfully executing over 1000 research studies across multiple therapeutic areas. Dr. Schwartz has done approximately 250 vaccine trials. The clinical team has built a solid reputation over the years by dedicating themselves to be a truly exceptional, first-in-class, independently owned and operated clinical research site – which consistently sets RCA apart from the standard.
Research Centers of America – DISCOVERING NEW TREATMENTS AND CHANGING LIVES.
