Responsive Approach To Large, Complex Trials
Conducting multi-site, late phase clinical trials demands agility. With a focus on capacity and scalability, iCardiac responds quickly to study requirements and ensures that all sites are well-trained and ready to collect accurate ECG data by the targeted first patient in. We currently support many Phase III trials as large as 750 sites in 28 countries with 14,000 subjects.
Rapid Protocol-Specific QT Alert Reporting with Dynamic Centralized Service
Responding swiftly to ECGs on which inclusion/exclusion decisions are based is essential in a Phase II or III trial, since no subject should be mistakenly excluded from a study. Our rapid, accurate ECG analysis for screening visits eliminates the false exclusion of subjects based on inaccurate ECG results, thereby speeding up study recruitment and achieving earlier database lock.
Case studies demonstrate that site-based ECG machines often report QT interval readings that deviate significantly from centrally measured QT readings by expert cardiac core labs like iCardiac, and more often site-based ECG machines indicate a longer QT reading than what is found by a core lab. iCardiac’s Rapid QT Alert service will report accurately corrected QT intervals back to sites before the patient leaves the office (usually 2 to 4 hours from collection), so that correct decisions about including or excluding a subject can be made by the sites in a timely manner. With Dynamic ECG Centralization, we can also tailor our service based on study requirements, from collecting data for a cardiologist review to storing it securely for a later analysis and reporting.
Global Capability: Service and Equipment Expertise
iCardiac is an experienced global service provider, with support personnel and cardiologists in North America, Europe and Asia. Our staff is fluent in 15 languages and their international experience and logistics expertise ensures that a study runs smoothly. Our easy-to-use equipment is distributed through global depots, reducing shipping delays and saving logistics costs. iCardiac deploys highly portable, durable, and reliable collection devices for the capture of cardiac safety data. Our ECG collection system was purpose-built for use in clinical trial settings, with real-time display of all 12 leads simultaneously, and with wireless connectivity. Auto-transmission of the ECGs immediately upon data collection ensures a rapid turn-around time from our central core lab.
Innovative and Easy-to-use Equipment Drives Study Success
- Lightweight, portable, and purpose-built for international clinical trials
- Dual-mode technology for capturing high quality ECG and Holter recordings
- Single device can be used for multiple protocols and studies
- Automated real-time data capture and collection
- Pre-populated drop-down menus for protocol-specific visit information
- ECG and Holter data automatically uploads via Internet
Reliable Data Delivery with Exceptional Customer Service
- Integrated data collection across sites and users
- Integrated electronic data transmission
- Centralized database management and monitoring
- Real-time signal quality control
- Centralized equipment programming and modification
- Prompt and thorough procedure review
- Rapid response to alert criteria
- One-time subject data entry with query rates below 5%
- Reports immediately available and accessible