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Premier Research has a long tradition in cardiovascular research for drugs and devices. The company was involved in the evolution of collection and monitoring of cardiotoxicity data for new molecular entities. More recently, we have supported the approval of many new devices including drug eluting stents, catheters, ablation systems, and cardiac assist devices, as well as critical pharmaceutical studies in the treatment of conditions.
Premier Research project team members have extensive clinical experience and training in cardiovascular disease studies. In the past five years, Premier Research has completed more than 105 studies and 35 consulting projects in this area involving more than 66,000 subjects.
Premier Research is well positioned to quickly execute cardiovascular studies for investigational products seeking regulatory approval as well as marketed drugs and devices with an intent to expand labeling, meet post marketing surveillance requirements for regulators, and to assess safety.
Cardiovascular disease is one of the leading causes of premature morbidity worldwide. The need for evidence-based research for
cardiovascular disease is paramount, especially given the current emphasis on the ‘Comparative Effectiveness’.
Getting the right answers requires an understanding of how to ask the right questions. Applying the right study design and the data
collection techniques combined with the correct data analysis will yield the evidence needed in today’s cardiovascular research development programs. Our biostatisticians with their clear understanding of cardiovascular disease provide sponsors with robust analytical design and analysis to ensure that trials provide clear measurement of treatment efficacy and safety. This is precisely what the marketplace requires and what the regulatory agencies mandate.
Successful execution of a well-designed study requires an experienced team. Our clinical experts with the local knowledge and expertise draw upon years of experience managing cardiovascular trials and relationships with networks of investigators with proven track records for subject recruitment and quality data. Our experts select the investigators (e.g, cardiologists, endocrinologists, general practitioners) and study site locations (e.g., academic institutions, specialty clinics, community- based sites) from our databases that are best-suited to meet the goals of each study and the objectives of the sponsor. Our teams are committed to efficient, effective study execution.
There is perhaps no other therapeutic area where interventional approaches have so dramatically changed the outcomes of not just acute cardiac care needs but long-term cardiac morbidity and mortality. Premier Research is among the most experienced CROs in interventional cardiology and more broadly, in medical devices.
The conduct of clinical research in interventional medicine requires knowledge of both device and pharmaceutical clinical development
and the appropriate regulatory path. Premier Research can provide this significant knowledge and apply its expertise to study design, statistical planning, and the operational aspects of your clinical program.
Further, patient recruitment for interventional cardiology studies require knowing the appropriate interventional cardiology sites
for each study. Premier Research is a leader in investigator selection and recruitment in this arena.
Our experience includes the following types of cardiovascular devices:
- Ablation Systems (RF and Ultrasound)
- Atrial Fibrillation Devices
- Baroreflex Stimulators
- Cardiac Assist Devices
- Cardiac Bioprostheses
- Cardiac Imaging Diagnostics
- Cardiac Pressure Monitoring Devices
- Catheters (Laser and Drug Eluting)
- Drug Eluting Balloons
- Mechanical Reperfusion Devices
- Optical Coherence Tomography Devices
- PFO Closure Devices
- PFO Sizer Devices
- Pulmonary Artery Pressure Sensors
- Stents (Bare Metal and Drug Eluting)
- Thoracic Endoprostheses
- Valve Replacements
- Vascular Access Devices
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