BOSTON--(BUSINESS WIRE)--Care Access announced today the completion of a for-cause Food and Drug Administration (“FDA”) Good Clinical Practices (“GCP”) inspection related to Care Access’s activities on the Pfizer VALOR trial. The inspection resulted in no FDA Form 483 observations, meaning the FDA investigator found no GCP violations by Care Access in the VALOR trial.

波士顿-（商业线）-Care Access今天宣布完成与辉瑞VALOR试验中的Care Access活动相关的原因食品和药物管理局（“FDA”）良好临床实践（“GCP”）检查。检查没有导致FDA 483表格的观察结果，这意味着FDA调查人员在VALOR试验中没有发现通过护理访问违反GCP的情况。

The FDA inspection lasted from October 2nd to October 10th, 2023, and was an in-depth review of Care Access’s contributions to the trial, including with respect to general GCP requirements, patient safety, and data integrity..

FDA检查于2023年10月2日至10月10日进行，是对护理访问对试验的贡献的深入审查，包括一般GCP要求，患者安全性和数据完整性。。

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..

今年早些时候，由于涉嫌GCP违规行为，辉瑞在该研究的护理接入点停止了3000多名参与者。Care Access不同意辉瑞的决定并拒绝了指控。FDA调查人员缺乏任何调查结果完全符合Care Access关于没有GCP违规行为的说法。。

“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.”.

“我们不能为我们的团队感到自豪，”护理访问首席执行官Ahmad Namvargolian说。“这证实了我们对护理访问的杰出系统和控制措施的了解，以确保其所执行的所有研究的监管合规性和患者安全性。我们很高兴有机会最终接受这项独立的搜索审查由FDA专家提供，该专家证实了我们在VALOR试验及其他方面的表现一直在说什么“。

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..

辉瑞VALOR研究正在进行中，旨在确定潜在的莱姆病疫苗的安全性和有效性。护理访问已经部署了其独特的分散模式，将这项研究带到以前无法到达的受莱姆病影响最大的社区。拥有一批移动研究车辆和一群旅行研究专业人员，Care Access专门从事临床研究以满足社区的需求，而不是相反。。

About Care Access

关于护理访问

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..

Care Access是一家全球研究公司，有助于加速新药的到来。拥有超过150个研究点的全球网络，Care Access支持前20位生物制药公司中的14家进行的研究。除了其在全球顶级注册网站上的可靠记录外，还与新的研究社区建立了护理访问合作伙伴，并在本地建立了高质量的研究网站基础设施，以扩大临床试验的访问范围并增加代表性。。

To learn more visit www.careaccess.com.

To learn more visit www.careaccess.com.