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Managers of FDA-regulated firms must be proactive in how they manage their company's compliance with good manufacturing practices (GMP) regulations. This article examines how a system of management controls can serve to support and maintain a company's GM…
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David Chesney. Vice President, PAREXEL Consulting |
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With a steep growth in the economy, urbanization, and more affluent lifestyles for some, Western-type diseases have begun to emerge in India. The increasing prevalence of oncologic, cardiovascular, respiratory, and diabetic disorders, central nervous syst…
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Anita Cooper, Corporate Senior Vice President and General Manager, Clinical Research Services, PAREXEL International |
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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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The development of new medicinal products is guided by internationally accepted principles and practices in the conduct of both individual clinical trials and overall development strategies starting from drug discovery, lead identification, and preclinica…
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Udo Kiessling, MD, PhD., Corp. VP and Worldwide Head of Medical Affairs Clinical Research Services, PAREXEL International |
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The differences between traditional generics and biosimilars are really quite fundamental. Biologicals are orders of magnitude more complex both in structure and in terms of impurity profile compared to small molecules. As a consequence of this increased …
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Cecil Nick, Principal Consultant, PAREXEL Consulting, UK |
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Since the 1950s, global pharmaceutical companies have invested billions of dollars in safety and monitoring systems to improve pharmacovigilance. Despite the tremendous expenditure of time and resources, the industry continues to experience unforeseen saf…
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Uwe Maennl |
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Abstract Recognised as a major health problem in developed countries, cancer in emerging regions accounts for a disproportionate number of cases with a higher ratio of mortality to incidence. This increasing incidence and the lack of resources, limited av…
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Denis R. Miller, M.D. |
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Risk management considerations for conducting clinical trials outside ICH regions.
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Gadi Saarony |
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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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DAVID SNODIN, Ph.D., VICE PRESIDENT, NONCLINICAL, PAREXEL CONSULTING GOPI K. VUDATHALA, Ph.D., ASSOCIATE VICE PRESIDENT, REGULATORY CMC, SANOFI AVENTIS US | |
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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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A Dozen Things to be Learned from European Biosimilar Development
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Ravi S. Harapanhalli, PhD | |
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Conducting an analysis of the 4Ms-- man, machine, methods and materials -- enables companies to identify the true root causes of deviations. This article explores unintended consequences of automatically using operator error as the root cause of performan…
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Vivian Bringslimark, Senior Consultant, PAREXEL Consulting |
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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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The problems frequently associated with ramping up processes from pilot plant stage to full-scale production may be tempered with foresight and planning. This article provides elements that need to be considered from technical and business perspectives an…
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Dr. Irach Taraporewala, Senior Consultant PAREXEL Consulting |
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Web-based forums allow ongoing contact with key opion leaders-on their schedule
For most pharma companies, key opinion leaders (KOLs) have become an increasingly important part of the team, throughout the entire lifecycle of product development. And at e…
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Alain Eudaric and Mike Gauthier of eTractions |