FDA Finds No Misconduct by Care Access in Pfizer’s Lyme Vaccine Trial
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. 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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231011141967/en/
Care Access mobile research vehicle at Martha's Vineyard clinic. (Photo: Business Wire)
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Empatica Announces Plans for Landmark Clinical Study to Develop an AI-Based Seizure Forecast Based on Wearable Real-World Data30.11.2023 14:29:00 CET | Press release
Empatica, a digital health and AI company developing medical-grade wearables and digital biomarkers for health monitoring and diagnostics, today announced plans to launch a first-of-its-kind study aimed at developing a seizure forecasting algorithm for people living with epilepsy, based on real-world data collected using its technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231130692933/en/ Empatica announces plans to develop an AI-based seizure forecasting algorithm based on wearable real-world Data (Graphic: Business Wire) More than 3 million Americans suffer from epilepsy, according to numbers from the Centers for Disease Control. And around one third of people with epilepsy have refractory epilepsy which occurs when medications no longer control seizures1. Epileptic seizures are disruptive health events that can have a significant negative impact on quality of life and increase risk of injury and death for peopl
QPS Holdings, LLC divests its Neuropharmacology Business Unit30.11.2023 14:15:00 CET | Press release
Today QPS Holdings, LLC (QPS) a leading drug development Contract Research Organization (CRO), announces an agreement to sell its Neuropharmacology business unit (QPS Neuropharmacology) to Scantox, a leading Nordic pre-clinical, GLP-accredited CRO. QPS Neuropharmacology, based in Grambach, Austria and focused on drug discovery, specializes in neurodegenerative diseases, rare diseases and mental disorders. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231130940694/en/ QPS Neuropharmacology facility in Grambach, Austria. (Graphic: Business Wire) Founded in 1999, QPS Neuropharmacology has built a strong global reputation for high quality services that are deeply scientifically rooted and has an undisputed track-record of serving a loyal and broad customer base globally. This long history of developing expertise within neuropharmacology preclinical studies has contributed to strong year-on-year growth and positioned the organiz
ASICS Teams Up with BlueConic for Enhanced Personalization and Data Privacy Compliance30.11.2023 13:00:00 CET | Press release
ASICS, the global leader in athletic footwear and apparel, has selected pure-play customer data platform (CDP) BlueConic to reimagine the way it engages with customers. The move will empower the ASICS team to support a growing number of personalization projects while remaining compliant with consumer data privacy regulations around the globe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231128796155/en/ ASICS teams up with BlueConic to deliver personalization at scale. (Photo: Business Wire) With operations across the Americas, Europe, the Middle East, Asia, and Oceania, ASICS is best known for its sports apparel, shoes, equipment, and accessories for men, women, and children. The company acquired fitness app RunKeeper in 2016 for its potential as a one-on-one marketing channel. With a focus on increasing engagement and loyalty both within the app and across brands, channels, and regions, ASICS will use BlueConic to unify
LTIMindtree Partners with Metasphere to Deliver Smart Sewers Solutions30.11.2023 12:00:00 CET | Press release
LTIMindtree [NSE: LTIM, BSE: 540005], a global technology consulting and digital solutions company, announced that it has been selected as a strategic partner by Metasphere, a wastewater application specialist, to scale their Smart Sewers management platform. As a part of this engagement, LTIMindtree will transform Metasphere’s next-generation wastewater monitoring solution portfolio, and enable scalable delivery and platform to their customers. Metasphere, part of Grundfos, provides smart network management solutions to the global utility industry. The company helps customers prevent leaks and spills for a cleaner, greener world and has deployed more than 200K sensors for their customers worldwide. By leveraging cutting-edge technology, the company offers intelligent, innovative, all-in-one wastewater application solutions. These solutions provide full network visibility, performance and forecasting that reduce telemetry ownership cost for customers to manage time-critical remote asse
LatticeFlow Announces Intelligent Workflows for Eliminating AI Blind Spots30.11.2023 09:00:00 CET | Press release
LatticeFlow, the next-generation AI platform for enabling enterprise teams to build performant, safe, and trustworthy AI at scale, is proud to announce Intelligent Workflows, to help machine learning engineers proactively rectify errors and ensure the reliability and robustness of AI model performance in production. This cutting-edge technology aims to revolutionize the AI industry by addressing one of the most critical challenges faced by machine learning engineers today. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231129791751/en/ (Graphic: Business Wire) With the proliferation of AI in business operations, the formidable task of seamlessly integrating high-performing AI models into real-world applications has grown increasingly critical. In particular, when dealing with large and complex datasets, ensuring production readiness for these models necessitates automation and a methodical approach to uncovering blind spots.