Applied Clinical Trials-05-01-2012

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Applied Clinical Trials

May 01, 2012

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

Applied Clinical Trials
View from Brussels

May 01, 2012

Clinical trials should meet ethical and GCP standards no matter where in the world they are conducted.

Applied Clinical Trials

Eric Abadie's resignation as Chair of the Committee for Medicinal Products for Human Use of the European Medicines Agency shocked the industry.

News
Applied Clinical Trials

May 01, 2012

One increasingly popular way to help ease the transition into a new role in the clinical trial space is through a mentoring program.

News
Applied Clinical Trials

May 01, 2012

At the DIA EuroMeeting in March a look at Health Technology Assessment (HTA) alongside regulatory authority initiatives was presented.

Applied Clinical Trials
View from Washington

May 01, 2012

Expanding access to nonprescription drugs and facilitating comparative effectiveness research.

Applied Clinical Trials
A Closing Thought

May 01, 2012

The adoption of new, consistent definitions are needed to help demystify late phase trials.

Applied Clinical Trials

FDA Draft Guidance "Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and postapproval Clinical Investigations" is reviewed.

Applied Clinical Trials

ISR Reports

Applied Clinical Trials

Better selection and tougher site management is not enough to improve enrollment success.

Applied Clinical Trials
Business News

May 01, 2012

Industry news focusing on the people and organizations who work in the clinical trials profession.

Oncology Clinical Trials
Applied Clinical Trials

May 01, 2012

Cancer trial recruitment is struggling-adult participation is limited.

Applied Clinical Trials
Feature Article

May 01, 2012

Survey results show that the recruitment of Latino subjects requires specialized tactics.

Oncology Clinical Trials
Applied Clinical Trials

May 01, 2012

Optimizing early phase trials key to the success of novel cytotoxics and targeted therapies.

Oncology Clinical Trials
Applied Clinical Trials

May 01, 2012

Are emerging markets the only answer to oncology clinical trial recruitment?

A job seeker's two most used tools are the cover letter and resume.

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.

Applied Clinical Trials

Medidata Solutions

Applied Clinical Trials
Feature Article

May 01, 2012

Understanding the United States' regulatory pathways and clinical operations.

Applied Clinical Trials
Clinical Trial Business Legacy

May 01, 2012

Where do CRO's turn next? What does pharma do about it?

Applied Clinical Trials
Clinical Trial Business Legacy

May 01, 2012

Continual change is coming as sponsors' sourcing requirements diverge from the major CROs.