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Imaging of bone serves as a well-recognized surrogate endpoint for monitoring the response to therapy of bone diseases, particularly the bone loss associated with osteoporosis. The author discusses the range of diagnostic imaging modalities available to c…
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Dr. Joel Feinblatt, Ph.D., Associate Medical Director, Perceptive Informatics |
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A product manager's most critical task is preparing a project plan for a global clinical trial. But what constitutes a successful plan, and how do you execute it in a landscape that has become increasingly more complex? Here's a clue - It's all in the pla…
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Diego Glancszpigel |
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Biomarkers and surrogate endpoints are becoming an important part of regulatory submissions and this is driving the development of medical imaging in clinical trials. The author discusses the main imaging technologies and their value in assessing new trea…
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Dr. Oliver Bohnsack, Associate Medical Director, Perceptive Informatics |
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Understanding and using adaptive trial design to achieve the most of its available advantages.
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Imogene Grimes and Barbara Tardiff, MD |
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The information needed to make decisions about clinical studies often already exists but is held in disparate places. By combining CTM and IVR clinical trial systems, sponsors can make their data available almost immediately
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John Humphreys, Principal Clinical Consultant, CTMS, Perceptive Informatics |
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Structuring the knowledge and expertise within the organization is key to a project plan that works.
The number of new clinical trials worldwide has increased significantly, forcing the biopharmaceutical industry to look for new markets to conduct studi…
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Diego Glancszpigel and Graciela Racaro |
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Interview with Mark A. Goldberg, MD, President of Clinical Research Services and Perceptive Informatics, PAREXEL International
The industry is buzzing with today's hot topics in outsourcing performance metrics, diversity and clinical trials. Throughout t…
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The first generation of eClinical technologies, such as Electronic Data Collection (EDC), Interactive Voice Response Systems (IVRS) and Clinical Trial Management Systems (CTMS), has been in use for a number of years; in some cases, a decade or more. These…
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Kate Trainor & Jean-Remy Behaeghel |
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A changing regulatory environment and difficult targets present significant challenges for biopharmaceutical companies seeking a balanced approach to risk management.
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Nayan Nanavati, Vice President, Peri-Approval Clinical Excellence, Americas |
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Leveraging technology is key to fulfilling the promise of automation and streamlining clinical trials. Simplifying, streamlining and integrating technology used in the clinical trial process will help make it less costly and time consuming, thus removing …
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Kate Trainor, Vice President, Integration Services, Perceptive Informatics |
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In the past, there have been some fairly extreme under-estimates of the inventiveness of mankind and the usefulness of some of its inventions. The internet, on the other hand, has been almost universally hailed as one of the greatest of all inventions. I …
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David Kill |
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On September 28, 2007, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) released a new guideline for the biopharmaceutical industry entitled "Basic Concept for International Joint Clinical Trials." The PMDA issued the guideline in response to gr…
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Mark A. Goldberg, President, Clinical Research Services and Perceptive Informatics Inc., PAREXEL International Corporation, USA |
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In the current competitive global market, you need uncomplicated access to a comprehensive breadth of services no matter your company size, global needs or therapeutic focus.
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A survey produced by health industry insights, an IDC company and sponsored by PAREXEL reported that the top three most important companies in working with performance metrics for biopharmaceutical companies in working with clinical research organizations…
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Joshua Schultz, Vice President of Clinical Research Services, PAREXEL International |
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Proactive risk management helps pharma protect their product development investments and futures. Proactive risk management is absolutely vital for every organization in today's fast moving global marketplace. As the recent worldwide financial crisis clea…
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Holger Liebig and Rebecca Hastings |
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Medical imaging in oncology trials is already well documented. Techniques such as CT, MRI and conventional radiology can provide insights into drug safety and efficacy faster than traditional clinical endpoints. Adopting an imaging strategy, however, int…
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Gaurav Sawhney, Barbara Chandler, Kelie Williams, Sandra Chica, MD, Perceptive Informatics |
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The biopharmaceutical industry has been relatively slow to embrace the advantages of long-term strategic partnerships that have benefited many other industries. Until recently, the majority of relationships between biopharmaceutical companies and CROs or…
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Joshua Schultz |