Applied Clinical Trials
April 01, 2017
News
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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.
April 01, 2017
News
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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.
April 01, 2017
News
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Is the much anticipated Europe action plan on personalized medicines, unveiled recently by an EU-sponsored international consortium, worth paying a close eye on?
April 01, 2017
News
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Application review will require closer cooperation between ethics committees and competent authorities in several areas.
April 01, 2017
Clinical Trial Insights
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Examining the evolution of protocol design and collaboration executing strategies.
April 01, 2017
News
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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.
April 01, 2017
A Closing Thought
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The language in Europe's Regulation (EU) 536/2014 regarding ethical review of protocols is concerning.
April 01, 2017
From the Editor
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Why following one consistent playbook for trial management should be at the core of outsourcing partnerships in drug development.
April 01, 2017
Feature Article
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How to assure that software used in clinical trials will support regulatory scrutiny during pre-approval inspections and application review.
April 01, 2017
Feature Article
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4
Examining the role of Clinical Research Malaysia in advancing industry-sponsored drug development in the country.
April 01, 2017
Feature Article
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Outlining current regulatory issues and views surrounding expanded access to investigational products in the U.S.
April 01, 2017
Feature Article
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How CROs and sponsors can step up their relationship game.
April 01, 2017
Issue PDF
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Click the title above to open the Applied Clinical Trials April/May 2017 issue in an interactive PDF format.