Clinical Research-Cardiac Safety

Global Instrumentation’s comprehensive cardiovascular safety solution is built on our proprietary M12A trial management software platform. From Phase I studies to large global multisite studies, the M12A provides CROs, core labs, and sponsors with a configurable and validated tool for the capture, processing, analysis, reporting and archiving of cardiac safety data.

GI understands that clinical trial requirements often cannot be satisfied with traditional healthcare products and therefore our suite of ECG products is specifically designed with the needs of clinical research in mind.

 

M12A CARDIAC SAFETY PLATFORM OVERVIEW

M12A SOFTWARE OVERVIEW

Continuous 12-lead Holter & resting ECG combined AND configured for clinical research

Automated Workflow Tools

Data acquisition auto-guidance allows the creation of easy-to-configure labels that auto-guides the data acquisition process and minimizes the need for later query corrections. Integrated ECG Export enables ECG waveforms to be exported in XML format for selected time points – delivering data in the FDA required format and is useful for interfacing to other proprietary systems.

Powerful ECG Review & Editing Tools

Continuous recordings can be parsed for discrete analysis of 12-lead segments or full Holter arrythmia analysis. Precise interval assessments, waveform and quantitative QT comparisons (baseline or serial) can be done quickly and confidently.

Efficient ECG Extraction Tools

The M12A software provides the ability to support highly-configurable 12-lead ECG extraction exports from long-term Holter recordings. Timepoints for the extraction exports are synchronized (anchored) with drug dosing for a better quantification and analysis of drug effects.

Audit Trails for Regulatory Compliance

System administrators can access and query the M12A system audit trails that report demographic, user, personnel, conclusions, archive operations and download requests to assist in achieving FDA Part 11 compliance.

Ambulatory Blood Pressure Analysis

Ambulatory Blood Pressure Monitoring (ABPM) data can serve as a surrogate endpoint for evaluating BP changes over circadian patterns, and are increasingly being considered by regulatory agencies for determining drug safety.

Android Application for ECG Data Collection

The M12A Android App collects data from the M12R or M12R L recorders and provides for a very low-cost and easy to deploy late phase study ECG collection system. Deployable on tablet or smartphone devices.

RECORDER OVERVIEW

Proven across years of research use, the Global Instrumentation family of ECG recorders provide the highest quality of ECG data. All devices seamlessly integrate with the M12A software application and offer BlueTooth™ connectivity for fast and efficient recorder set-up an initialization.

2 in 1 Device for Core ECG Acquisition

The M12R Device can be configured to record continuous ECG (Holter Mode), to record intermittent real-time recording (ECG Capture), or to run both modes simultaneously. The recorder can be configured to acquire either 3-channel or 12-lead ECG by just changing the patient cable.

  • All data is stored and transmitted in full-fidelity with sample rates of up to 1,000 samples per second with ultra-high resolution of 0.5 microvolts.
  • Bi-directional communication via Bluetooth™ provides fast verification of patient hook-up and provides real-time data transmission to PCs and Android-based mobile devices.
  • The M12R uses low-cost standard SD data storage cards that are easily removable to enable immediate recorder reuse.
  • Unlike traditional “cart” ECG devices, the M12R can easily be shared across multiple studies through preserving study encapsulation of data.

Simple & Powerful Recorder for Resting ECG

The M12R L is a portable and wireless 12-lead ECG data acquisition recorder that pairs with the M12A Clinical Research Software Application to provide efficient digital centralization of ECG screening and safety study data.

  • All data is stored and transmitted in full-fidelity with sample rate of up to 500 samples per second with ultra-high resolution of 0.5 microvolts.
  • Bi-directional communication via Bluetooth™ provides fast verification of patient hook-up and provides real-time data transmission to PCs and Android-based mobile devices.
  • Data collected by the M12R L can be easily centralized on a PC or server.
  • Digital capture and report generation eliminates time consuming and inefficient scanning of paper ECG reports produced by cart ECG devices.

Our Smallest Recorder for Home Holter Data Collection

The M3R is a small & compact Holter monitor capable of storing up to 3 days of data on a single set of batteries. Ideal for ambulatory/home data collection in later phase studies.

  • Only 3.8 in x 2.2 in x .7 in size and 7 oz in weight for patient comfort in ambulatory (home/work) environment
  • Up to 3 days recording duration on a single AA battery
  • 2 or 3-Channel ECG at 200 samples per second data rate
  • LCD display provides real-time ECG traces to enable easy confirmation of patient hook-up quality.

Best-in-Class Ambulatory Blood Pressure Monitoring

The Oscar 2™ system from SunTech Medical® sets the standard in 24-hour ambulatory blood pressure monitoring (ABPM) by utilizing proprietary motion-tolerant technology, meeting the highest clinical standards, and optimizing patient comfort. Clinicians are provided practical interpretive analysis incorporating the latest monitoring advances.

  • Patented Orbit cuff is specifically engineered for ambulatory blood pressure monitoring applications with a soft sleeve that gently hugs the arm to maintain cuff placement and provide the ultimate in patient comfort for an extended period of time.
 

REQUEST A DEMO

Experience how Global Instrumentation enables the faster delivery, distribution, and analysis of ECG and ambulatory blood pressure data.