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Applied Clinical Trials-05-01-2012
Applied Clinical Trials
Applied Clinical Trials Digital Edition - May 2012
May 01, 2012
Issue PDF
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SUBJECT RECRUITMENT : Latino Recruitment - Motivations and Tactics REGULATORY : Medical Device Trials - Regulatory Pathways and Clinical Operations Also in this issue : Clinical Testing Challenges, Ethics in Europe, Enrollment Performance, Phase Labels
Ethics is all the Rage in Europe
May 01, 2012
View from Brussels
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Clinical trials should meet ethical and GCP standards no matter where in the world they are conducted.
It's All Change at the Top for EMA
May 01, 2012
News
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Eric Abadie's resignation as Chair of the Committee for Medicinal Products for Human Use of the European Medicines Agency shocked the industry.
Mentoring New Employees
May 01, 2012
News
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One increasingly popular way to help ease the transition into a new role in the clinical trial space is through a mentoring program.
HTAs: Using Endpoints in Clinical Trials
May 01, 2012
News
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At the DIA EuroMeeting in March a look at Health Technology Assessment (HTA) alongside regulatory authority initiatives was presented.
Real-World Clinical Testing Challenges
May 01, 2012
View from Washington
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Expanding access to nonprescription drugs and facilitating comparative effectiveness research.
Are Phase Labels Still Relevant?
May 01, 2012
A Closing Thought
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The adoption of new, consistent definitions are needed to help demystify late phase trials.
FDA's Safety Data Collection Draft Guidance
May 01, 2012
News
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FDA Draft Guidance "Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and postapproval Clinical Investigations" is reviewed.
Enrollment Performance: Weighing the "Facts"
May 01, 2012
CTI Insights
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Better selection and tougher site management is not enough to improve enrollment success.
Business and News Update May 2012
May 01, 2012
Business News
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Industry news focusing on the people and organizations who work in the clinical trials profession.
Recruitment Drivers
May 01, 2012
Oncology Clinical Trials
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Cancer trial recruitment is struggling-adult participation is limited.
Tailored Latino Recruitment
May 01, 2012
Feature Article
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Survey results show that the recruitment of Latino subjects requires specialized tactics.
Early Phase Trials
May 01, 2012
Oncology Clinical Trials
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Optimizing early phase trials key to the success of novel cytotoxics and targeted therapies.
A Data Driven Approach
May 01, 2012
Oncology Clinical Trials
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Are emerging markets the only answer to oncology clinical trial recruitment?
Industry Tips to a Perfect Resume, Irresistible Cover Letter, and Stand-Out Interview
May 01, 2012
News
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A job seeker's two most used tools are the cover letter and resume.
Two Months and Counting on EU Pharmacovigilance Implementation Deadline
May 01, 2012
News
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The EMA issued seven draft guidances of the 16 modules for good pharmacovigilance practice in February. There has been confusion and concern among sponsors over how to implement a legislation with no clear guidance from the EMA.
Medical Device Trials
May 01, 2012
Feature Article
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Understanding the United States' regulatory pathways and clinical operations.
What to Know About CROs
May 01, 2012
Clinical Trial Business Legacy
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Where do CRO's turn next? What does pharma do about it?
Outsourcing Landscape
May 01, 2012
Clinical Trial Business Legacy
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Continual change is coming as sponsors' sourcing requirements diverge from the major CROs.