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Clinical Research Services
LifeWatch Research Services provides the technology and services that enable pharmaceutical, biotechnology, medical device and academic research industries to collect, interpret and distribute cardiac and other clinical data more efficiently. We are a market leader in providing centralized electrocardiography services and leading technologies that streamline clinical trial processes to enable our customers to automate many parts of a clinical trial. Our clinical research operations are conducted through offices in the United States.
- Intelligent workflow-enabled arrhythmia monitoring, data collection, database management, communication and reporting system for handling digital and paper-based electrocardiography (ECG) data and images.
- Centralized analysis and cardiologist interpretation of ECGs performed on research subjects enrolled in clinical trials permits assessment of the safety and/or efficacy of therapies by carefully measuring and documenting the occurrence of cardiac electric charge.
- Fully Title 21 CFR, Part 11 compliant to address the emerging global regulatory guidance and technical standards for digital ECG processing that includes digital collection, waveform measurements and annotations, review and output to the regulatory standard file format.
- Digital ECG data collected via a number of electrocardiography devices.
- New technologies and automated programs streamline the processing of test procedures from receipt through electronic data reporting, resulting in a comprehensive, high quality service provision.
ECG Processing Support:
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Bar-coded paper ECGs for audit trail; double-smart data entry for clean demographic data where required |
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Integrated high-quality digital interval duration measurement process
meeting FDA requirements for quality digital data |
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Interface to LifeWatch Support Services for timely source processing, query resolutions and
clean data reporting resulting in fewer queries at data lock |
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Web-based physician interpretation capability with electronic signatures for
efficient and timely interpretations and built-in audit trail accounting |
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Remote web-based secured and validated access worldwide of meaningful, timely and customizable reports |
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Production of complete ECG image databases for electronic storage and hot link retrieval |
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