- Strategic collaboration amplifies accessibility to Clario’s Early Precision QT (EPQT) methodology, enabling biopharmaceutical firms to secure more accurate and cost-efficient cardiac safety data in early clinical development stages.
- Meticulous multi-stage evaluation positions Dr. Vince Clinical Research as an ideal candidate for intricate trials, leveraging integrated technologies, state-of-the-art telemetry, and deep clinical expertise.
- In many cases, data collected through the partnership can sufficiently fulfill ICH E14 regulatory requirements and qualify Sponsor companies for a Thorough QT study waiver.
OVERLAND PARK, Kan. & PHILADELPHIA, pa.; August XX, 2023 – Dr. Vince Clinical Research (DVCR), an early phase Clinical Research Organization (CRO), today announced a new collaboration with Clario, a leading healthcare research and technology company that delivers leading endpoint technology solutions for clinical trials.
The partnership will extend access to Clario’s clinically proven Early Precision QT (EPQT) methodology. In many cases, this data can sufficiently fulfill International Council for Harmonization (ICH) E14 regulatory requirements and qualify Sponsor companies for a Thorough QT study waiver. Together, DVCR and Clario will empower more biopharmaceutical companies to obtain precise and cost-effective cardiac safety data earlier in the clinical development process.
“In order to initiate this strategic partnership, DVCR’s Phase I clinical pharmacology unit underwent a rigorous evaluation process to become a Clario Certified Site,” Robert Kleiman, M.D., Chief Science and Regulatory Advisor, Cardiology, Clario, commented, “It was quickly obvious that the clinical pharmacology unit built by Dr. Vince Clinical Research is exceptionally well-suited to conduct these complex trials given the site’s integrated technologies, state-of-the-art telemetry system, and deep clinical experience. Their organization is already skillfully leveraging Clario’s platforms to provide high-quality cardiac data to our clients.”
Dr. Kleiman added, “The certification process involves collecting continuous cardiac data in a mock clinical trial environment, in accordance with Clario’s guidance documents and using their standardized data collection forms. The collected data was analyzed by Clario’s experts to ensure that each extraction timepoint meets their robust standards for data quality and integrity. As a result, two of DVCR’s personnel were designated as “Site Champions.”
The partnership with Clario makes use of the latest technology. The Wi-Fi-enabled 12-lead telemetry system archives data on-site and directly uploads it to Clario’s cloud-based portal. Site staff can remotely monitor tracing quality, reducing data collection interruptions, and improving the experience of study volunteers by reducing the number of electrodes placed on them, leading to improved volunteer retention.
Brad Vince, D.O., DVCR’s CEO & Medical Director, stated, “The successful qualification of our Phase I unit as a Clario Certified Site represents multiple years of planning and a commitment to being a trusted partner in this space. We are excited to be working alongside Dr. Kleiman and Dr. Darpo to leverage Clario’s expertise in cardiac safety.”
The partnership between Clario and DVCR marks a significant milestone in the clinical research industry, setting a new standard for cardiac safety data collection during Phase 1 clinical trials.
About Clario
Clario is a leading healthcare research and technology company that generates the richest clinical evidence in the industry for our pharmaceutical, biotech and medical device partners. Across decentralized, hybrid and site-based trials, our deep scientific expertise, global scale and the broadest endpoint technology platform in the industry allows our partners to transform lives. Clario has the only technology platform that combines eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. With 30 facilities in nine countries, Clario’s global team of science, technology and operational experts has helped deliver over 24,000 trials and 870 regulatory approvals for over five million patients in 120 countries. Our innovation has been transforming clinical trials for 50 years.
For more information, go to Clario.com or follow us on LinkedIn and Twitter.
About Dr. Vince Clinical Research
Dr. Vince Clinical Research (DVCR) is a full-service contract research organization (CRO) specializing in early phase trials in both healthy normal volunteers and patient populations across a wide range of trial designs and therapeutic areas such as neuroscience, substance abuse, pain, cardiometabolic disorders, infectious diseases and many others. CRO services include project management, data management, biostatistics, statistical programming, PK/PD analysis, medical writing, monitoring as well as site feasibility and management for multi-site trials. Additionally, DVCR operates one of the most innovative and technologically advanced clinical pharmacology units in the world with over 90 beds for overnight confinement, a cGMP compliant pharmacy as well as luxurious amenities to support diverse study participant recruitment and retention. By leveraging technology and one of the country’s most experienced leadership teams in early clinical development, DVCR provides Smarter Faster Data® to their biopharmaceutical clients.
For more information, go to sponsors.drvince.com. Connect with Dr. Vince Clinical Research on LinkedIn and YouTube.
Clario Media Contact
Duncan Cantor
Sr. Director, Corporate Communications
media@clario.com
DVCR Contact
Zach Bader
Vice President, Business Development
(913) 333-3000
Dr. Vince Clinical Research
info@drvince.com