Pharmaceuticals companies, biotech companies, and CROs,
regardless of size, all face the same challenge of managing costs
and operational execution associated with bringing a valuable drugs
and devicesto market. Because of timeline pressures and cost as
well asthe growing interest in "neglected diseases" and diseases
affecting the emerging nations, clinical trials are increasingly
conducted in emerging markets and developing countries where
infrastructure, leadership, skilled personnel and a governance are
at a premium.
Working with academics, regulatory professionals, safety
officers, experts from the pharma industry and CROs, the editors
have put together thisup-to-date, step-by-step guide book
tobuilding and enhancingglobal clinical trial capacity inemerging
markets anddeveloping countries. This book covers the design,
conduct, and tools to build and/or enhance human capacity to
executesuch trials, appealing toindividuals in health ministries,
pharmaceutical companies, world health organizations, academia,
industry, and non-governmental organizations (NGOs) who are
managing global clinical trials.
* Givesmedical professionals the businesstools needed to
effectively execute clinical trials throughout the world
* Provides real world international examples which illustrate
the practical translation of principles
* Includes forms, templates, and additional references for
standardization in a number of global scenarios"
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