Worldwide Leader in Centralized Clinical Trials

Transcription

Worldwide Leader in Centralized Clinical Trials
Worldwide Leader in
Centralized Clinical Trials
Cardiac Safety Services
Minimizing variability in data by dedicating cardiologists & standardizing
equipment and processes.
Digital 12-Lead ECG | TQT/Intensive Studies | Holter Monitoring | Cardiac
Event Monitoring | Ambulatory Blood Pressure | ECG Stress Testing (ETT)
Impedance Cardiography | Mobile Telemetry
Pulmonary Function Services
Exclusively offering dual pulmonary data review, a technical and professional quality
review of all loops per ATS/ERS recommendations.
Spirometry | Peak Flow/E-Diary | Challenge Testing | Pulse Oximetry | Nitric Oxide
Forced Oscillometry | DLco/Lung Volumes
Imaging Services
Matching global experts to protocol objectives to maximize the accuracy and
validity of data.
MRI | X-Ray | PET or PET/CT | Echocardiography | CT | DXA |Ultrasound | Actigraphy
Angiography | SPECT | PWP Recordings | Nuclear Medicine | Video & Photography
Digital Pathology | Audio Evoked Potential | EEG Sleep Medicine | Electromyography
Scientific Affairs
Providing innovative international researchers dedicated to framing and refining
diagnostic data processes.
Regulatory Communication Assistance | Data and Safety Monitoring Board Meeting
Support/Training | Clinical Development Strategy | Data Analysis/Interpretation
Protocol Development/Review | General Consulting | Biostatistics | Report Writing
ePRO Solutions
Accommodating electronic patient reported outcome needs utilizing both validated
and non-validated questionnaires for clinical trials or consumer health care projects.
Web-based ePRO | Site ePRO | Home ePRO
Highest Regulatory Standards
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Fully approved FDA/EMEA systems and processes for clinical trial central data management and medical assessments.
Complies with ATS/ERS guidelines and 21CFR11 for Pulmonary trial software & equipment. Completed successful not-
for-cause FDA audit in 2010.
Extensive Global Coverage
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Offers secure, encrypted remote reading systems allowing access to international expert analysis of data.
Allows interim transfer of cleaned Imaging data at anytime in any format (SAS, Oracle, ASCII, etc.) to sponsor.
Includes 24/7/365 support from dedicated project management teams operating in the US and Europe.
Providing Logistics support via four global, centrally located offices in the US, Europe, India, and Japan.
Supports studies in 95 countries.
Superior Medical and Technical Expertise
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Incorporating subspecialty trained medical experts in Cardiology, Radiology, Pathology, etc. from around the globe.
Including project management teams with several years of clinical research trial experience.
With a comprehensive background in Pediatric trials of all modalities.
Building central Imaging clinical trial qualifications via more than 250 recent studies featuring global investigator sites.
Premier Innovation
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Featuring BMS Gateway™, the industry’s best proprietary system for central management of: ECG, Spirometry, Pathology, and Medical Imaging data.
First core lab to offer Digital Pathology in clinical trials.
Offering TruVue®, a revolutionary wireless ambulatory ECG monitoring system.
Featuring CardioPulmonary Suite, a proprietary software for combined studies in ECG, Spirometry, ABPM, Peak Flow, and NiOx.
Preeminent Market Experience
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With the stability of more than 35 years same ownership and name including over 25 years of market presence in clinical trials.
Including more than 99% of investigative sites that are protocol and study compliant.
Comprehensive Central Medicine Review Services
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Offering the most extensive range of Imaging modalities.
Exclusively providing centralization of processes and readings for clinical trials involving: Imaging, Digital Pathology, EEG, Cardiac Safety, TTM, and Spirometry.
One Contact, Multiple Solutions
Biomedical Systems has set the health care industry standard by providing innovative approaches to noninvasive
diagnostic services, clinical trials, and products. We provide clients with the ability to increase cost efficiencies and
bring studies to database lock on an advanced timeline by combining any of our over 20 modalities in one
study. Biomedical Systems’ pioneering spirit is based on a strong history as a privately held company
that focuses on clients and people. We continue to invest in advanced technologies to meet the
ever-changing needs of our clients. Take advantage of our full suite of clinical trial services.
www.biomedsys.com
For more information, please contact a Biomedical Systems’ Representative
at +1-800-877-6334 in North America, +32-2-661-20-70 in Europe,
+81-29-886-7221 in Japan, +91-413-22-22-016 in India, or visit our
website at www.biomedsys.com.