The required identification of any QT/QTc interval prolongation and proarrhythmic potential for new non-antiarrhythmic drugs is based on the Food and Drug Administration's ICH E14 industry guidance. Since the guideline's inception, there has been continued focus on the effect new drugs have on cardiac repolarization. The need for a thorough, well-designed and effectively executed QTc trial with statistical significance lies at the heart of submitting an NDA.
Specialists
Experience. Availability. Ability to recruit. The objective criteria from which to select a CRO for conducting your TQT trials can be summarized by these three factors.
Cetero has conducted over 10,000 trials, including more than 38 definitive TQT trials. With Cetero as your partner, you have access to a state-of-the-art facility fully equipped to perform cardiac safety trials.
With over 1,700 beds — 146 of which are dedicated hospital beds — we have the largest bed capacity of any CRO. Why split your study into small cohorts, when our hospital bed capacity can accommodate large single study groups for quicker study conduct turnaround. In fact, our largest enrollment of a single cohort included 70 subjects, while the largest TQT trial completed to-date included 280 subjects.
Cetero has also successfully recruited over 2,500 cardiac safety trial participants over the past two years. We not only can accommodate your trial in one place but also with the least number of study groups.
Early Phase
Integrating QT assessments within your Phase I trial provides you with the necessary data to make critical decisions early in the drug development process. Accurate data allows you to effectively develop and design later phase trials.
Late Phase
At this point, the study design is unique to your compound's pharmacodynamic and pharmacokinetic characteristics. We provide you with an advantage—the ability to partner with a CRO that can conduct the trial in one place with one study group. With so many variables in clinical research; the number of groups in your definitive trial should not be one of them.
Our partnerships with core laboratories, like eResearch Technology (eRT), the flexibility to work with other ECG laboratories, combined with the expertise of our clinical personnel, assures accurate data collection and interpretation. We will work with you to ensure effective collaboration and data collection.
Exacting Science. Personalized Service.
Cetero's standards are exacting and stringent. Our team follows clearly documented quality control protocols to ensure consistent and accurate results. We provide a full spectrum of services, all while making our company easy to do business with. Cetero's professional and personable staff readily accessible throughout the planning and conduct of your trial.
Cetero is your cardiac safety specialist.
Cetero's clinical pharmacology units are fully equipped to coordinate any QTc trial—and all are backed by our experienced medical staff.
TQT/QTc capabilities
- 12-lead continuous ECG H-12 holter recording
- Electronic data capture system – study monitor
- Alliances with several core central ECG labs
- Experience with the following systems:
- Mortara H-12 holters
- Mortara H-12+ holters
- Mortara ELI 250
- Mortara E-Scribe Software
- Telemetry
- Ambulatory Blood Pressure monitoring
Dedicated Clinical Team
- Experienced physicians and nurses
- Trained medical project teams
- Two fulltime Internal Medicine physicians
- Team of data management and report specialists
- Guidance on study conduct and protocol development
Cetero Services
Clinical Pharmacology Unit
- 120 hospital beds
- Experienced Medical Staff
- Efficient recruiting
- Optimized study conduct
- Project management
Scientific Affairs
- Protocol development
- Data management
- Pharmacokinetic/Pharmacodynamics
- Biostatistics
- Medical writing
- ICH reports
Bioanalytical
