Applied Clinical Trials, Apr 1, 2009 - Applied Clinical Trials

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Applied Clinical Trials, Apr 1, 2009
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From the Editor
Make That an "e" Please
By Lisa Henderson
A recent roundtable discussion on eCTD highlights issues related to the industry wide switch from paper to electronic.
News
Costs and Utility in Biomarker Use
By Lisa Henderson
Considering the cost and value of biomarkers when deciding to use them in a clinical trial.
Path to Self-Employment
By Marissa Shapiro
A survey says independent contracting is gaining popularity among clinical trials professionals.
BIO Breeds Hope
By Kerri Nelen
May convention provides golden opportunity for industry to collaborate and to strategize for a better future.
Global News
Italy Heightens Rules for CROs
By Philip Ward
Regulatory authorities in Italy enforce new legislation that hardens the requirements for education and certification of staff at CROs.
eShowcase
eClinical Software
By Lisa Henderson
The latest eclinical software in the clinical trials industry.
View from Washington
Health IT Offers Both Promise and Problems
By Jill Wechsler
Biomedical research community finds privacy policies add cost and complexity to clinical studies.
View from Brussels
The Rarity Value
By Peter O'Donnell
As EU debates plans for advancing R&D in rare diseases, industry assesses the risks and benefits.
Technology Viewpoint
Observational Data Under the Microscope
By Wayne R. Kubick
Learning how such data can provide a real-world view of drug safety and effectiveness.
Feature Article
Strategic Comparator Sourcing
By Tony Dutta
Effective ways for sponsors to reduce risk when embarking on comparative clinical trials.
CRO Selection & Management
By Harold E. Glass , Daniel P. Beaudry
Study reveals how sponsors rate their own outsourcing abilities compared to other companies.
EDC Project Success
By Richard F. Pless
What it takes to get all stakeholders on the same page and keep project timelimes on track.
RESCUE Medical Writing
By Robin Whitsell
Two case studies illustrate the potential to turn chaos into meaningful clinical study reports.
Community
Business and People Update
By Marissa Shapiro
Industry news focusing on the people and organizations who work in the clinical trials profession.
A Closing Thought
Comprehensive Feasibility?
By Uma Arumugam, MD
Developing and utilizing a comprehensive feasibility strategy to avoid risk and ensure the most efficient clinical trial.

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