Spacelabs Medical Data

Since its origins from Spacelabs Medical, which began in support of the Gemini and Apollo Space Programs, Spacelabs Medical Data has provided state-of-the-art cardiac safety and diagnostic services to the clinical research industry. Spacelabs Medical Data commenced its operations in 1985 with the landmark CAST Study (Cardiac Arrhythmia Suppression Trial). Spacelabs Medical Data provides global, centralized 12-lead ECG, Holter monitoring and ambulatory blood pressure monitoring (ABPM). We have provided centralized cardiac safety services to over 100 pharmaceutical and biotech companies, device manufacturers, CROs and universities in studies ranging from single site to 350 international sites and 45,000 individual procedures. We provide international services with offices in the US and Europe and a multi-lingual support staff.

Spacelabs Medical Data leads the way in helping our clients comply with the requirements of the ICH E14 Guidance Document. ICH E14 addresses the risk of Torsade de Pointes in non-cardiovascular drugs by requiring a comprehensive Phase I Thorough QT/QTc study. In addition, the FDA requires that all ECG tracings from such studies be submitted for review by the agency in the E-Scribe ECG Warehouse. We obtained Mortara Certified Partner status for the E-Scribe ECG Warehouse by demonstrating that our data is compatible with the FDA XML format required for submission. We use the research-inspired ELI 250 Rx electrocardiograph and H12+ Holter monitors, both which provide 1000Hz resolution to ensure the high level of precision required for a Thorough QT/QTc study. In addition, our choice of technology provides flexibility in study design.

As the industry pioneer and a leading in providing ABPM services to the clinical trials industry, we utilize the gold-standard Spacelabs Medical 90207 ABP monitor. The 90207 has been the most frequently used ABPM in published clinical trials. We have leveraged our relationship with our parent company to develop a proprietary, hand-held PDA interface that provides immediate access to patient data.

In addition, we provide full consultation services including protocol design, sample size, and expert reports.

Spacelabs Medical Data provides the following Centralized Cardiovascular Services:

12-Lead ECG

We provide state-of-the-art static ECG services with the research-inspired Mortara ELI 250 Rx electrocardiograph. The ELI 250 Rx has an LCD screen that provides intuitive data entry menus and real-time ECG display. The ELI 250 Rx can print a full-size ECG at the site complete with interpretation by the VERITAS' algorithm. The ELI 250 Rx can store up to 150 tracings and transmit them to our servers via modem or LAN with a single push of a button. The tracings are confirmed by our cardiologists using customizable terminology and coding sets.

Holter Monitoring

Spacelabs Medical Data employs Mortara H12+ digital Holter recorders that can provide up to 24 hours of 12-lead ECG data at 1000Hz sampling rate or up to 48 hours of continuous 3-channel recording. This versatility allows the monitor to be used for rate and rhythm analyses, ischemia assessment and QT/QTc intensive studies. 12-lead Holter monitoring in QT/QTc intensive studies provides further flexibility in study design. Data transfer to our central laboratory is available either with high-speed electronic transfer or via flashcard by courier.

QT Intensive Studies

Spacelabs Medical Data provides study design, statistical analyses and regulatory consultation for QT intensive studies. We provide cost-effective solutions for early stage non-thorough QT/QTc studies as well as standard Thorough QT/QTc studies. We provide increased flexibility in study design with both a static ECG and Holter solutions to these types of studies.

Ambulatory Blood Pressure Monitoring

Spacelabs Medical Data uses only the industry gold standard Spacelabs Medical Model 90207 ABPM. The monitor is interfaced with a hand-held PDA device for monitor initialization, data collection, and immediate analysis for protocol eligibility, safety and dosing determinations, and technical success criteria.

Spacelabs Medical Data is headquartered at Spacelabs Medical's state-of-the-art research, administration, and manufacturing campus in Issaquah, WA.

Spacelabs Medical Data's list of satisfied research customers includes over 100 pharmaceutical and biotech companies, universities, CROs and device manufacturers for which hundreds of thousands of procedures have been completed. Spacelabs Medical Data is open during international business hours and our multi-lingual staff supports international studies.

Contact Information

Spacelabs Medical Data
Marc Hagan, General Manager
5150 220th Ave SE, PO Box 7018
Issaquah, WA 98027-7018 USA
Phone: 425-657-7237, 800-657-6901
Fax: 425-657-7215
E-mail:

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