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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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Patient recruitment, extensive equipment requirements, and consistent data quality were major challenges for a program of global Phase II and Phase III trials addressing Chronic Obstructive Pulmonary Disease (COPD). Despite these challenges, PAREXEL achie…
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PAREXEL |
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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 biosimilar concept has the potential to produce affordable new biotech medicines, but only if industry and regulators work together on a harmonised global approach, says Cecil Nick.
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Cecil Nick |
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“Biosimilars will eventually bring
down the cost of biological
medicines and in doing so will
expand the market.”
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Cecil Nick |
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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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Cecil Nick | |
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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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Patient recruitment, drug availability, and regulatory hurdles were major challenges for a five protocol, global Phase III program addressing Rheumatoid Arthritis, Psoriatic Arthritis, & Ankylosing Spondylitis. Despite these challenges, PAREXEL achieved r…
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By Hoss A. Dowlat, PhD | |
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More than 1,200 patients were recruited at over 200 sites in 32 countries, 4 weeks ahead of schedule. This complex Phase III study of a first-line treatment for colorectal cancer required a global recruiting effort that included Europe, Latin America, Afr…
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Interview with Lars-Olof Eriksson, PhD, MSc, Vice President of START
In 2007, prior to that year's DIA meeting, Parexel announced its Start-up and Accelerated Recruitment Team (START). Now, two years later, the Team has added to its base of experts, as w…
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