Earlier this year, Pfizer discontinued over 3,000 participants at Care Access sites on the study due to alleged GCP violations. Care Access disagreed with Pfizer’s decision and rejected the allegations. The lack of any findings by the FDA investigator is wholly consistent with Care Access’s assertions that there were no GCP violations.
“We couldn’t be prouder of our team,” said Care Access CEO Ahmad Namvargolian. “This confirms what we’ve known all along about Care Access’ outstanding systems and controls to ensure regulatory compliance and patient safety on all the studies it performs. We’re very glad to have had the opportunity finally to undergo this independent, searching review by an FDA expert, which confirmed what we’ve always said about our performance on the VALOR trial and beyond.”
The Pfizer VALOR study is ongoing and seeks to determine the safety and efficacy of a potential Vaccine for Lyme Disease. Care Access had deployed its unique decentralized model to bring this study to previously unreachable communities that are most impacted by Lyme Disease. With a fleet of mobile research vehicles and a team of traveling research professionals, Care Access specializes in having clinical research meet the needs of a community, not the other way around.
About Care Access
Care Access is a global research company helping to accelerate the arrival of new medicines. With a global network of over 150 research sites, Care Access supports research studies conducted by 14 of the top 20 biopharmaceutical companies. In addition to its proven track record of globally top-enrolling sites, Care Access partners with new-to-research communities and establishes high-quality research site infrastructure locally to expand access to clinical trials and increase representation.
To learn more visit www.careaccess.com.
