Centralized DLco/Lung Volumes in Clinical Trials

According to the American Thoracic Society’s Single-breath Carbon Monoxide Diffusing Capacity (Transfer Factor) Recommendation for a Standard Technique, “Measuring an ‘overall’ CO uptake by single-breath technique has proved useful in assessing a variety of lung abnormalities that impair alveolar capillary gas transport. Moreover, in many diseases, the magnitude of abnormalities in DLCO has been shown to correlate with disease severity and with direct measurements of arterial blood oxygenation, especially during exercise.” Centralized DLco testing in a clinical study offers clients the ability to diagnose and treat lung disorders not found by either spirometry or chest x-ray. In clinical screening of patients with some types of lung disease, DLco testing can demonstrate a significantly impaired gas exchange where no significant defect in the mechanics of breathing is found. Such patients may also have a normal chest x-ray, so that only reduced DLco offers evidence of lung disease.

As the measurement of lung volumes including Residual Volume (RV), Functional Residual Capacity (FRC), and Total Lung Capacity (TLC) are sophisticated tests, they require qualified and experienced staff to accurately coach patients in obtaining the most repeatable results. Lung volume data measurements may be of significant importance in tracking air trapping and the effectiveness of therapies targeting the COPD population.

Relying upon site-owned equipment, Biomedical Systems utilizes standardized software, standard operating procedures, and intensive quality reviews monitor pulmonary lab quality control measures and help ensure clients receive accurate, reliable data in DLco and Lung Volume clinical trials. We believe the support offered by our pulmonary data technicians, registered respiratory therapists, and technology experts makes our service offerings unequaled in the industry. Biomedical Systems provides services and support for our clients around the clock via our four centrally located global offices in North America, Europe, and Asia.

Pulse Oximetry
in Clinical Trials

Pulse Oximetry is a non-invasive technology measuring the oxygen saturation of a patients’ blood on a continuous basis. Respiratory therapists may monitor patients at rest or while exercising to discover evidence of pulmonary vascular disease, determine if limitations are pulmonary or cardiovascular, and assess clinical trial treatment response. Overnight studies may be useful in screening patients who desaturate during sleep. Pulse Oximetry technology can be helpful in satisfying a protocol’s safety requirement and is an essential component in the 6 minute walk test.

In 1998, Biomedical Systems pioneered the centralization of pulse oximetry using standardized equipment and software designed to meet the protocol specifications, ensure data security, and transmit data automatically. Programmable screen alerts support uniform testing by site personnel and the acceptance of only data that meets pre-set quality standards. Biomedical Systems’ approach to centralized pulse oximetry data includes providing our clients with standardized equipment and software, disposable supplies, protocol specific training manuals, and extensive quality control reviews both manual and electronic. In support of these services, Biomedical Systems offers experienced project management teams and unmatched customer service and technical support through any of our offices in North America, Europe, or Asia.