Applied Clinical Trials, Jun 1, 2007 - Applied Clinical Trials

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Applied Clinical Trials, Jun 1, 2007
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From the Editor
What's In Your DIA?
By Lisa Henderson
DIA's Annual Meeting: one part learning, one part reunion, one part research, and one big event.
Guest Commentary
EDC: Caught in a Trap
By Timothy Pratt, PhD
Some starry-eyed vendors can't turn their back on older technology because they're too attached.
Lessons from TGN 1412
By Stephen Senn
How applying statistics to the design, conduct, and analysis of Phase I trials can improve clinical research.
View from Washington
Demand Grows for Comparative Studies
By Jill Wechsler
Added information to inform treatment decisions may drive up research costs for sponsors.
View from Brussels
EU Think Tank Takes on R&D Bottlenecks
By Peter O'Donnell
Group recommends ways to improve and increase clinical research in new report.
Technology Viewpoint
Computerized Systems Guide a Go at FDA
By Paul Bleicher
Release of final Guidance is a step in the right direction for Agency and trials.
Feature Article
Data Integration: Past & Future
By Solomon Shacter
Emerging technologies are moving the industry closer to true IT solutions harmonization.
Saving Time and Money
By Carol Rozwell , Rebecca Kush , Ed Helton
New report based on findings from a 2006 research project adds up savings using CDISC standards.
Three-Dimensional Image Security
By Zheng Zhou , Brent Liu , H.K. Huang
LDSE security technology ensures privacy, authenticity, and integrity of 3-D clinical trial image exams.
Impact of EDC on Clinical Staff Roles
By Franziska Falk
In addition to study timelines and budgets, EDC adoption directly affects the people who run trials.
EDC Progress Steady for Europe and Asia
By Philip Ward
EDC is being embraced by both continents, where its efficiency is welcomed despite a few kinks.
The Value of Digital Signatures in E-clinical Applications
By Gadi Aharoni , Rodd Schlerf
They're crucial in e-clinical applications, and thanks to new solutions, no longer out of reach for smaller companies.
eCTD Guidance Takes Center Stage
By Jay Johnson
Five-module architecture organizes massive amounts of information included in a marketing submission.
The State of E-clinical Technology
By John Cline
E-solutions are on the rise and gaining favor with FDA, as resistance finally gives way.
Project Management Evolves with Technology
By Anne Wiles
The roles, knowledge, and skill sets of team members also need to adapt with real-time data technology.
Internet Resources
Internet Resources Guide
Selected Web sites to assist readers in becoming more informed about available clinical trials as well as related news and other information.
A Closing Thought
Under the Hood: EDC
By Bill Claypool
New alternatives for e-clinical and data management. As EDC becomes more widely used in clinical trials, sponsors are not limited to one option but rather can choose different routes to optimize EDC efficiency.
eShowcase
eShowcase: Global eCTD Guidance Interpretation
Common Framework and Organized eCTD Submissions Goal of New Software Product
eShowcase: Clinical Conductor
Web-Based CTMS Solution Specifically for Investigative Research Sites
eShowcase: Adaptive Trials Simulation Toolkit
Adaptive Trials Simulation Toolkit Addresses New Ways to Run Clinical Trials

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