Showing items tagged as Clinical management

  • Data Integrity Starts With User Access

    March 10, 2015 Jamie Colgin, Colgin Consulting

    In my next few blog posts, we'll be covering user access and how it can impact data integrity. For starters, let's explore the Principle of Least Privilege. What is it?  What happens when it's violated? Finally we'll map out five actions you can take to protect your company.

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  • From Good to Great – The One Skill Great CRAs Possess

    October 23, 2014 Holly Deiaco-Smith, MS

    Don’t get me wrong, these skills are important and they are point of entry for a good CRA. These skills are expected as a minimum set of skills to be hired for the job of CRA but they are not the skills that differentiate a great CRA. 

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  • FDA Issues New Q&A On Data Integrity

    September 2, 2014 Jamie Colgin, Colgin Consulting, Inc.

    Recently FDA published a new set of seven questions and answers. Three questions cover data integrity and e-signatures. While the Q&A target GMP, there are lessons to be learned for all of us:

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  • Be SMART: 5 Critical Factors in CAPA

    March 4, 2014 by Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    It’s not enough to come up with a corrective action for a quality event. It’s critical to have the right action that actually fixes the problem and prevents it from recurring.

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  • What’s in Your Training Toolkit?

    January 29, 2014 David Hofstetter, Manager, Learning and Development at New England Organ Bank

    Do we do a good enough job at identifying the real issue or are we in such a hurry to meet a requested deadline that we simply take the word of the requestor? How do we know we are truly solving the issue and not just meeting a request? 

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  • 6 Ways to Leverage Risk-Based Monitoring & Clinical CAPA

    November 14, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    A big part of the cost of developing a new drug can be attributed to clinical research, which typically lasts at least eight-and-a-half years.  For this reason, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are emphasizing the need to mitigate clinical-trial risks (1).

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  • The Rising Costs of Clinical Trials

    January 31, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl

    One of the most costly areas of business for any Pharmaceutical or Biotechnology Company has always been clinical research. Now more than ever the cost of bringing a product to market is staggering and as patents on trademark products expire the hope for recovering costs of research get smaller and smaller.

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