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Sponsors are using echocardiography to examine the structural health of the heart in clinical trials. Echocardiography is a non-invasive test that will allow Sponsors to view the anatomy, structure and function of the heart including:
- Complete cardiac chamber dimension
- Cardiac wall thickness, left ventricular mass
- Segmental wall motion analysis
- Cardiac valvular structure, function and competency
- Cardiac chamber pressures and filling capacities
- Contrast Echocardiography, including perfusion studies
(All acquired and measured according to ASE guidelines)
Due to the technical and sophisticated nature of the test, it is extremely important to work with a centralized core lab that has an expertise in echocardiography. With Biomedical Systems, you’ll work with one of our Board Certified Cardiologists Level III Echocardiographer who can assist or completely design your protocol to meet specific Sponsor and FDA requirements. Sites also receive protocol specific training at investigator meetings, teleconferences or videoconferences by the cardiologist or Registered Diagnostic Cardiac Sonographer designated to your study. In addition, Biomedical Systems offers comprehensive group training sessions at our coorporate office and/or one to one on-site training.
Biomedical Systems Echocardiography team is skilled in 2D, M-Mode, Contrast Agents and Doppler. Some of the advantages of working with Biomedical Systems include:
- Site certification for quality of echocardiograms ensures protocol is followed by site designated personnel and correct views are acquired.
- Registered Diagnostic Cardiac Sonographer ensures equipment has the required capabilities. Test echocardiogram is submitted before the study start with site notification via quality report form within 48 hours of receipt at Biomedical Systems.
- Analysis includes, but not limited to, ejection fraction, cardiac output, fractional shortening, left ventricular volumes, and left ventricular mass
- Specific Doppler measurements required to evaluate left ventricular diastolic function. Increased sensitivity of specific protocols designed by Biomedical Systems permits earlydetection of diastolic dysfunction/heart failure before overt changes in ejection fraction are seen.
- Single Board Certified Cardiologist Level III Echocardiographer interpretation for all subjects minimizes variability.
- Technical site support provided by a Registered Diagnostic Cardiac Sonographer.
For more information on Biomedical Systems Centralized Echocardiography Services, please click here.
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Biomedical Systems Expands
Digisonics Digiview System
For Remote Reading
Biomedical Systems, a global provider of
centralized diagnostic services for clinical
trials, has expanded its DigiView network
from Digisonics to include additional
workstations for review, analysis and
reporting of cardiovascular studies.
Biomedical Systems’ physicians interpret
clinical studies using the DigiNet Pro system,
and rely on secure, web-based cardiovascular
image analysis and reporting from virtually
anywhere at anytime to ensure timely
completion of research projects. DigiNet
Pro provides Biomedical’s global readers
full edit and measurement capability from
over 11 countries simultaneously: the
United States, United Kingdom, France,
Spain, Portugal, Germany, the Netherlands,
Belgium, Mexico, Canada, Puerto Rico,
Colombia and Argentina.
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“In the clinical trial industry meeting
critical milestones is crucial,” said Beth
Gregory, director of echocardiography
for Biomedical Systems. “Using the DigiNet
Pro software allows our readers the
flexibility to maintain their active lifestyle
without interrupting the trial flow." |
DigiSonics Digiview For Remote
Access Readings
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