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Volume 12, Issue 2, February 2005
Article 397: CROs, EDC Companies Partnering for eClinical Trials Adoption
Summary
- Despite the benefits of implementing eClinical trials, including reduced costs
for pharmaceutical sponsors, many CROs have resisted transforming from traditional
paper-based clinical trials to electronic environments. In particular, CROs whose
main business involves managing clinical trials are not anxious to switch to a
process that could require fewer monitors and less billable hours. Some CROs have
seen EDC vendors as competitive threats.
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Article 398: Zeroing in on Microdosing
Summary
- Industry observers expect the number of microdose studies, also called human
phase 0 trials, to increase in the United States once the U.S. Food and Drug
Administration this month issues a draft guidance that will ease preclinical
safety data requirements for microdose studies, making it easier to conduct
them as exploratory studies rather than traditional phase I programs. During
the past year, acceptance of microdose studies has grown more quickly in Europe.
The growth of phase 0 could cut into the rapid rise of phase I trials, which
sponsors have also used to kill drug candidates earlier.
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Article 399: WHO Prescribes Research and Pricing Policies for Europe
Summary
- Europe should offer more public support and strong incentives for industry
to do clinical research in areas overlooked by market forces, according to a new
report from the World Health Organization (WHO).
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Article 400: Eye on: Parkinson’s Disease
Summary
- Parkinson’s Disease affects more than 500,000 Americans.
clinicalhome has identified a pipeline of 23 drugs in development for Parkinson’s.
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