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General Inquires |
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Qualia understands that drug development programs require the identification of QT/QTc prolongation through the conduct of Thorough QT/QTc or Definitive QT trials. Focus cannot be overstated in the proper assessment of cardiac safety for new drugs, in compliance with ICH/FDA/EMEA guidelines. United States and European regulatory agencies continue to emphasize the inclusion of ECGs in clinical trials to ensure patient safety before drugs are cleared for marketing.
Qualia has the right expertise, experience, systems & technology to ensure success on your upcoming cardiac safety trials.
Hands-On Experience
Team Qualia offers combined experience on over 50 TQT trials, and the expertise to deliver accurate results with full confidence. Qualia utilizes experienced cardiologists and principal investigators to conduct our cardiac safety studies. Our seasoned project management team’s hands-on experience includes:
- Coordination of all logistical set-up to ensure proper flow of study events and information
- Initializing monitoring procedures
- Determining critical values with PI, monitoring QT changes, and assisting in interpretation of QT interval changes
- Setting up holters and maintaining recordings from holters
- Working alongside ECG vendors to result in accurate transmittal of information
Leading Centralized ECG Partners
Through our partnerships with leading ECG core labs such as eResearch Technology, Inc. and Biomedical Systems, Qualia offers continuous 12-lead telemetry monitoring, in addition to standard 12-lead ECG and holter services. Qualia is an official partner of eRT (visit ert.com for details.) Accurate and thorough data collection, interpretation and archiving are essential to the success of drug development. In collaboration with our partners, we provide core laboratory services that specialize in the central management of Phase I - IV global clinical
trials using:
- Crossover & Parallel studies (up to 250 subjects)
- 12-lead Continuous ECG Monitoring for definitive QT trials
- 12-lead ECGs for Phase I, safety ECGs in definitive QT trials
- 12-lead ECGs for multi-center, late-stage (Phase II through Phase IV) trials
- 24/7/365 client services center
Qualia is an official partner of eResearch Technology, Inc. (ERT) Visit www.ert.com for details.
Well-Equipped & Controlled
The study design itself is individualized based on the compound’s pharmacodynamic and pharmacokinetic characteristics, therefore the trials must occur in a well-controlled, equipped clinical research facility.
- Phase I clinic with 160 beds (22 hospital beds dedicated for intensive studies)
- 3 board certified Principal Investigators with a very hands-on approach
- Dedicated & experienced project management team
For additional information, please contact your Qualia Business Development representative or
email: bd@qualiaclinical.com
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