FEATURED ARTICLES
This is a topic that has caused much consternation in pharmaceutical companies and has, in my experience, caused some clinical trials and even NDAs to fail due to an inadequate number of analyzable patients. By Bart Cobert
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Considerations In Using Foreign Trial Data In U.S. NDA Submissions
More and more drug companies are finding it financially advantageous to conduct clinical trials in foreign countries and to include data from these trials in NDA submissions. When offshore trials are properly conducted and the data is properly handled, this strategy can accelerate approval and lower the cost of drug development. By Ken Phelps, Camargo Pharmaceutical Services
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Streamlining The Workflow of CRCs: Understand the Challenges, Provide Solutions
Clinical Research Coordinators (CRCs) play a crucial role at sites in ensuring that research is conducted in a GCP-compliant manner. In many cases, processes could be streamlined to foster greater efficiency and quality in operations. In order to improve the processes, the challenges of current workflows must first be understood.