In our April/May issue:
Check out ACT's new look – a sleeker, simplified presentation, packed with more content and new special feature coverage! Drop us a tweet or email to let us know what you think!
FEATURED
Clinical Outsourcing: A Partnership Playbook
Lisa Henderson
In our latest featured theme report, ACT explores the world of CRO-sponsor partnerships—and, from the perspective of both sides, discusses new ways each can step up their relationship game to make the trial management process better.
PEER-REVIEWED ARTICLES
Regulatory Navigation for ‘Paperless’ Trials
Jules Mitchel, PhD, Jonathan Helfgott
Assessing the impact of electronic systems on several areas of a clinical trial is becoming a common fixture in routine pre-approval inspections and application review. Authors present a guide to assuring eSource tools used for studies will support regulatory scrutiny.
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Expanded Access Debate
David Vulcano
A look at the regulatory balancing act when it comes to weighing decisions on patient access to pre-approved products in the U.S.—and the potential merits of state-level control in cases of compassionate use.
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Emerging Markets: An R&D Linchpin
A.J.A. Ooi, K.F. Khalid, MD
This report highlights the role of Clinical Research Malaysia in advancing the country's drug development ecosystem to keep pace with the overall growth of clinical trials and investigator presence in Asia-Pacific.
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NEWS
Washington Report: Jill Wechsler explores the rise of rare disease drugs and subsequent regulatory and development hurdles.
EU Report: Peter O’Donnell on whether EU's new personalized medicines action plan has real game-changing potential.
Global Report: Philip Ward details Europe's renewed focus on boosting the quality of “complex studies.”
Regulatory Reform: Why closer cooperation in meeting Europe's new Clinical Trials Regulation is critical.
Data Standards: Analyzing one approach to applying regulatory data standards across the product lifecycle.
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CLINICAL TRIAL INSIGHTS
Development Operations Struggles: What Gives?
Ken Getz
How evolving complexities in protocol design and inconsistent collaboration execution have contributed to continued inefficiencies in development operations—and new strategies industry hopes will change the picture. |
CLOSING THOUGHT
Ethics and the Clinical Trials Regulation
Ernst A. Singer, MD
Unlike the current Directive, the language in EU Regulation 536/2014
raises several issues regarding ethical review.
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If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - lisa.henderson@ubm.com
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