Category: Life Sciences

  • Unpacking the Complexities of Clinical Data Submission Standards

    What is the deal with Dataset-JSON?

    Unpacking the Complexities of Clinical Data Submission Standards There is a storm brewing in the world of CDM (Clinical Data Management) and regulatory submissions. Since I came across the news that the FDA are considering Dataset-JSON as a new standard for submission I have conducted a lot of research to distil the wealth of information…

    Read More: What is the deal with Dataset-JSON?
  • Extracting Clinical Data from Legacy Systems

    How do I extract clinical data from old systems?

    Efficient Extraction of Clinical Data from Old Systems This article explores the challenge keeping clinical data in an old system and suggests various methods of extraction. Challenges of Old Systems Managing data in an old system presents several challenges that impact the efficiency and effectiveness of managing a clinical trial. Some of the key issues…

    Read More: How do I extract clinical data from old systems?
  • What is Clinical Data Management

    What is Clinical Data Management (CDM)?

    People, Processes, & Disciplines of Clinical Data Management Last week I had the pleasure of attending the ACDM conference in Copenhagen, Denmark. On my return to the UK I started to wonder if the term Clinical Data Management (CDM) is clearly understood. In my opinion it does not only refer to the people and processes…

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  • Why do we need so much functionality in software?
    Why do we need so much functionality in software?

    So Much Functionality in Software This article explains how much of software functionality we tend to use and explores why there are so many features to choose from. We end with offering a few suggestions for how to expand your knowledge of unused features. Unused Functionality in Software Research conducted by The Standish Group about…

  • What is the deal with Dataset-JSON?
    What is the deal with Dataset-JSON?

    Unpacking the Complexities of Clinical Data Submission Standards There is a storm brewing in the world of CDM (Clinical Data Management) and regulatory submissions. Since I came across the news that the FDA are considering Dataset-JSON as a new standard for submission I have conducted a lot of research to distil the wealth of information…

  • When do we know there is a problem to be solved?
    When do we know there is a problem to be solved?

    Knowing When a Problem Should be Solved I have been pondering the question “When do we know there is a problem to be solved?”, for a while. Typically, we recognise there is a problem when we have unmet needs, there are inefficiencies in a process, we receive complaints or feedback, we notice tends in data,…

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