CoreLab Partners - Centralised Medical Image Analysis and Cardiac Safety & Efficacy Services White Papers

Ambulatory Blood Pressure Monitoring CoreLab Partners is an international provider of 24-hour ambulatory blood pressure monitoring (ABPM) with more than 36 years of cumulative research experience. As a result of CoreLab Partners' efforts over the last decade, ABPM data are now included in most regulatory submissions for antihypertensive drugs, serve as a surrogate endpoint to describe the changes in blood pressure over 24 hours (circadian pattern), and are increasingly considered for determining new drug ef cacy and safety during regulatory review.
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DXA Services Dual energy X-ray absorptiometry (DXA) is an efficient, noninvasive, low-radiation dose measurement of bone mineral content (BMC), bone mineral density (BMD), and total body composition (fat and fat-free mass). It's currently the most common imaging tool used to determine BMD for disease processes such as osteoporosis. DXA offers low-radiation dosing (1/10 of the typical chest X-ray), rapid scan time, and ease of use. These distinctive attributes make DXA widely popular in the clinical research arena especially in trials employing bone density as a safety or efficacy endpoint.
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Oncology Imaging
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Molecular Imaging Whether your prospective compound or novel radiotracer is in the early or late stage of trial development, CoreLab Partners' Molecular Imaging services can be leveraged to successfully gather, analyze, and deliver crucial functional imaging data. For early phase trials, we work with you to provide highquality imaging efficacy data that empowers you to expedite critical go/no-go decisions. Your project team will be able to identify ineffective compounds earlier, saving valuable time and resources, while allowing only your most promising compounds to advance in your drug-development pipeline.
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Medical Image Interpretation & Assessment
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Digital ECG CoreLab Partners is internationally recognized as a leading provider of ECG services with more than 25 years of experience in the collection, management, and analysis of ECGs. With experience working alongside the ICH and FDA in the development of regulatory and industry guidelines, CoreLab Partners is best positioned to aid you in the design and conduct of your next cardiac safety and efficacy study.
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CoreLab Partners Brochure CoreLab Partners are focused on delivering centralised trial services in a proven, cost-effective operational model; on time and on budget boasting a record 100% on time deliverables on all projects to date. Please download this free brochure for more information.
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No Supplement for Safety Boaz Mendzelevski, director of Cardiology at Medifacts International, Inc. continues his investigation into cardiovascular safety in drug development, focusing on drug-induced vascular thrombosis and myocardial ischemia and infarction.
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Safety First Cardiac  safety  is  a  relatively  new  field  in  drug  development  clinical  research. It  first  emerged  as  a  regulatory  focus  after  the  high‐profile  withdrawals  of  drugs  such  as  terfenadine  and  cisapride  in  the  1990s,  and  became  synonymous  with  drug‐induced  QT  prolongation  and  its  associated  cardiac  arrhythmia  –  torsades  de  pointes  (TdP).  Recent  regulatory  guidance,  most  notably  ICH‐E14,  brought  cardiac  safety  into  the  forefront  of  regulatory  medicine. Since  2000, cardiac safety became the primary reason for drug withdrawals and non‐approval of new drugs. Early detection of potential QT  prolongation  and  TdP  liability  is  now  an  essential  component  of  the  drug  development  paradigm. 
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