FDA

Interactive voice response systems are a good match for adaptive clinical trials and can help keep investigators in the dark.

Why an electronic document management system is key to getting bought by major pharma.

Regulators and sponsors encourage alternative review models to fit a growing research enterprise.

With today's clinical investigators awash in regulatory burdens, it's high time sponsors provided a lifeboat.

UK report on last year's TGN 1412 trial provides industry with blueprint for improved early clinical studies.

A Q&A with members of CDISC and an executive in the software solution & services industry that explores the organization's efforts, capabilities & relationships.

Shift in Congressional control opens door to probes into research practices & expansion of PDUFA legislation.

AstraZeneca's interpretation of the EU Clinical Trial Directive: An industry perspective

Patient safety, orphan medicines featured in EU's six-year research support budget.

A changing research enterprise requires clearer policies and more effective regulatory tactics.

Along with the titles and phone numbers of personnel, View from Brussels columnist Peter O'Donnell gives an update on the regulatory front in Europe.

This newly updated glossary includes even more terms relevant to clinical trials professionals.

This document from HHS and OHRP provides IRBs with instructions for reviewing trial information listed on Websites.

These translations help make sense of initials commonly used by clinical researchers around the world.

There's plenty to tackle this month, including a debate over efficacy, new ARDS guidelines, and evidence the EMEA is listening.

Under IOM's plan, a "lifecycle approach" to drug evaluation would change FDA's pre- and postapproval policies.

Michael Murphy, President and CEO of Gentris Corporation, answers questions about his company's recent expansion into Japan.

Successful efforts of the organ donation sector could serve as a model for rebuilding public trust.

To realize the goal of the directive, member states need to collaborate and make improvements.

Instructions for evaluating adverse event data and guidelines for taking the proper course of action

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.

Confusion over policies governing prisoners points to the need for clear, uniform safeguards for all research.

The group's latest ODM release strengthens global reach and lets researchers define conditions in eCRFs.