Applied Clinical Trials April 2017

April 2017 | Volume 26, Issue 4
Applied Clinical Trials April/May 2017
News
The rise of new drugs targeting rare disease ignites increased push for flexible R&D approaches and more collaboration on orphan drug designation and clinical trial design between global regulators.
The European Forum for Good Clinical Practice to examine the impact of current regulations and areas such as big data and quality management on so-called complex studies.
Is the much anticipated Europe action plan on personalized medicines, unveiled recently by an EU-sponsored international consortium, worth paying a close eye on?
Application review will require closer cooperation between ethics committees and competent authorities in several areas.
The implementation of the International Organization for Standardization identification of medicinal products (IDMP) is a key step to ensuring that information on new innovations are identified and captured accurately within the regulatory framework and beyond.
From the Editor
Why following one consistent playbook for trial management should be at the core of outsourcing partnerships in drug development.
Clinical Trial Insights
Examining the evolution of protocol design and collaboration execution strategies.
Feature Article
How to assure that software used in clinical trials will support regulatory scrutiny during pre-approval inspections and application review.
Examining the role of Clinical Research Malaysia in advancing industry-sponsored drug development in the country.
Outlining current regulatory issues and views surrounding expanded access to investigational products in the U.S.
How CROs and sponsors can step up their relationship game.
A Closing Thought
The language in Europe's Regulation (EU) 536/2014 regarding ethical review of protocols is concerning.
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