Impact of EU Directive on Clinical Development
To realize the goal of the directive, member states need to collaborate and make improvements.
Assessing Safety in Clinical Trials
Instructions for evaluating adverse event data and guidelines for taking the proper course of action
eShowcase: eCTDXPress Aspire
Regulatory submission solution addresses the needs of smaller biotech and pharma companies
eShowcase: LabPas CT 2.5
Phase I package adds formulary accountability, recruitment, lab, and EDC features
Informed Consent Considerations
There are a number of factors potential subjects need to consider when deciding whether to participate in a clinical trial, including an often overlooked matter that this month's authors examine: taxes.
eShowcase: GlobalView EventNet
System enables IRB members to review ?s in near real-time from anywhere in the world
Subject Protection Issues Gain Broad Support
Confusion over policies governing prisoners points to the need for clear, uniform safeguards for all research.
Data Management: R.I.P. or Brave New World?
As more companies adopt eClinical technologies, data managers must redefine and update their role.
Hurricane Katrina: What Have We Learned?
The importance of human subject protection, clear communication, and community spirit are among the issues emerging from the tragedy.
Broad Introduction to CTs
An insightful review of Remedica's 2005 Clinical Trials: A Practical Guide to Design, Analysis, and Reporting
CDISC Standards Energize EDC
The group's latest ODM release strengthens global reach and lets researchers define conditions in eCRFs.
Deploying Mobile Devices in Clinical Trials
Practical guidance for effectively integrating PDAs and other handheld devices into CTs
Adopting Orphans: Who Does it Best?
A new report from the European Union grades member states on their orphan drug incentives.