IRB Featured Articles

1. Breaking The Blind In Clinical Trials & Reporting To Health Authorities, Investigators & IRBs/Ethics Committees 2/12/2013

   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

2. FDA's December 2012 Guidance On IND And BA/BE Reporting - Part II 1/22/2013

   Continuing with the review of the key points in FDA’s guidance.  This is the second of three postings. By Bart Cobert

3. Strategic Application Of Regulatory Pathways For Medical Devices 11/15/2012

   The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) signed into law by President Obama last July is a sweeping piece of legislation that, among many other provisions, enacts reforms aimed at improving various FDA regulatory procedures, including the medical device review and approval processes.  By Evan L. Rosenfeld, MD, JD, FCLM, Vice President of Medical and Scientific Affairs, Medical Device and Diagnostics, Theorem Clinical Research

4. Considerations In Using Foreign Trial Data In U.S. NDA Submissions 8/3/2012

   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

5. Streamlining The Workflow of CRCs: Understand the Challenges, Provide Solutions 5/1/2012

   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.