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We learned a lot during the first wave and have made significant safety enhancements to give our patients the comfort that we are a safe, experienced and highly professional organization to work with.
COLUMBUS, OH, July 30, 2020 /24-7PressRelease/ -- Aventiv Research, today announced plans to participate as a study site for, and begin enrolling participants into, the Phase 2/3 global study sponsored by Pfizer Inc. and BioNTech SE of an investigational vaccine, BNT162b2, against SARS-CoV-2, the virus causing the current global pandemic. The Aventiv Research study site is one of more than 120 clinical investigational sites around the world that will collectively enroll up to 30,000 participants.
Dr. Samir Arora has been a Principal and Sub Investigator involved in Phase I-IV clinical research on over 200 studies and serves as primary Clinical Trial Investigator at Aventiv's Columbus, Ohio location. "We have a large facility on the East side and have had to repurpose some areas of our office to accommodate for the large numbers of participants that will be coming through," commented Arora. "We learned a lot during the first wave and have made significant safety enhancements to give our patients the comfort that we are a safe, experienced and highly professional organization to work with."
About the Phase 2/3 Study
The Phase 2/3 study is an event driven trial that will continue enrollment on a rolling basis, enroll up to 30,000 participants at more than 120 clinical investigational sites around the world, in non-pregnant adults 18-85 years old.
The Phase 2/3 trial is designed as a 1:1 investigational vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. The trial's primary endpoints will be prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. Secondary endpoints include prevention of severe COVID-19 in those groups.
People interested in participating in the study through the Aventiv Research site can visit www.aventivresearch.com or call (614) 501-6164 to find out more.
About Aventiv Research
Aventiv Research exists to make novel medicines accessible to its patients and deliver industry-best pharmaceutical data to its sponsors. Its mission is to enrich the lives of both its team members and patients by putting medical research to work. Currently operating in three states with five independent research sites, Aventiv specializes in phase I-IV pharmaceutical, device, and diagnostic clinical trials in a variety of therapeutic areas. Built on the core values of dedication, integrity, resourcefulness, and professionalism, the company embraces a visionary, entrepreneurial spirit that compels its ambassadors to blaze new trails with proprietary systems and processes.
Founded in 2007 by Dr. Samir Arora, a proven leader with more than 15 years of clinical research experience, Aventiv Research has conducted over 450 clinical trials with more than 55 pharmaceutical sponsors and has helped 15 drugs to become approved by the FDA and available for use.
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