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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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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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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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Explosive development of new targeted therapy
for cancer and blood disease has generated
fierce competition for investigators and patients.
This causes serious problems for companies
trying to bring these innovations to market
in a timely and cost-effecti…
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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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With a full scope of services from First in Man through Proof of Concept, the PAREXEL global network of early phase clinical units tests compounds in healthy volunteers and patients, helping you make valuable decisions quickly and safely.
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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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PAREXEL’s dedicated CNS Therapeutic Area team
provides the experience and resources to help your
bio/pharmaceutical company take advantage of the
growth opportunities and overcome obstacles in every
phase of CNS drug development.
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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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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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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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The many regulatory differences and their evolution implied by the spectrum of clinical trial emerging markets in which to conduct clinical trials clearly emphasizes the need for growing clinical logistics expertise as those regions of the world themselve…
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Alain Eudaric, Director of Clinical Logistics Services |
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The PAREXEL Cardiovascular Therapeutic Area Practice
can help you meet these challenges with well planned,
efficiently managed and on-time trials worldwide. We
provide you with best-practice management across the
entire therapeutic area, including drug de…
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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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Clinical Logistics Services (CLS) helps
to eliminate costly and frustrating delays
by providing centralized coordination of
clinical trial supplies, lab services, and
ancillary supplies around the world.
Working as an integral part of PAREXEL’s
Clinical R…
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