Tag Archive: pivotal studies

Jan 17 2013

Enrichment Strategies for Clinical Trials

On 14 December 2012, the FDA released the guidance Enrichment Strategies for Clinical Trials to Support Approval for Human Drugs and Biological Products.  The guidance is intended to provide strategies for drug developers to enrich enrollment for responder subjects in both early and pivotal clinical trials.  Often, simply enrolling subjects that have the disease that …

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Nov 10 2011

Free Webinar – Optimal Clinical Study Designs and International Regulatory Strategies

Please join us at a joint webinar between the Netherlands Centre for Human Drug Development (CHDR) and Cato Research that addresses current challenges and provides clinical and regulatory strategies to the most expeditious and cost-effective path towards clinical proof of concept and approval. The webinar will be held on Tuesday, 15 November 2011 from 1:00 to 2:00 PM ET.

May 26 2011

Conference Recap – 2011 ACRP Global Conference and Exhibition

The 2011 Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition was held on 30 April – 03 May 2011 in Seattle, WA. The conference hosted 2,000 registrants including physicians, nurses, pharmacists, clinical research coordinators, clinical research associates, and other clinical research professionals.

Jul 07 2010

505(b)(2) Marketing Applications – Bridging the Gaps

There is no doubt that the drug development business is very expensive and development can take many years before a viable, money-generating product can be marketed. A strategy some of our clients implement to more quickly and more inexpensively develop a novel therapeutic product is to develop a drug that can rely on studies from …

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May 10 2010

Analysis of FDA Guidance on Adaptive Designs

In February 2010, the FDA published a draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics (“the guidance”). This highly anticipated guidance has come out in draft form 4 years after then FDA deputy commissioner Dr. Scott Gottlieb’s famous keynote speech on the topic accelerated interest on the topic. In the intervening years, …

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