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 • • 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 • • • • • 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 • • • • 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 • • • • 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 • • 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 • • 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.