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  • 29 Sep, 2017

    What are Combined Phase Trials?

    By Philip Day
    Combined Phase Trials combine all phases of a clinical trial. They go from one clinical trial phase to the next, seamlessly, saving money and time. They also reduce time and cost of conducting the study. (Also known as “Adaptive Trials”) Part of Combine Phase Trials is Master Clinical Protocol which is a new kind of clinical ...
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  • 31 Aug, 2017

    The Clinical Trial Startup

    By Editor
    A typical Clinical Trial Startup is usually delayed because of poor planning. The project manager has to hire a strong, professional clinical trial team. Then, processes such as SOPs and trial templates take time. If they fail to get these done, the clinical trial is delayed. The clinical trial project manager can have those systems in place ...
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  • 14 Jul, 2017

    Why Do Clinical Trials Fail? (Part 2)

    By Editor
    Project Managers often have to deal with an unproductive team. It is a challenge that the project manager has to troubleshoot. There are many possible reasons that the team does not perform well. The Project Manager needs to find the root cause and fix it, as soon as possible or the clinical trial is in danger ...
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  • 07 Jul, 2017

    Why Do Clinical Trials Fail? (Part 1)

    By Editor
    Clinical trials fail. That is a fact of life as a recent study (2015, Clinical Development Success Rates for Investigational Drugs) found that 90 percent of drugs that reach clinical stage development never make it to FDA approval and commercialization. Only half of all drugs are rejected during the process and fail due to a lack ...
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  • 30 Jun, 2017

    FDA Regulation of Software in Clinical Trials

    By Editor
    Not all software is regulated by FDA. Some software may be regulated depending on what it does. You can take a lot of what we know about clinical trials and design them for the task. FDA does not regulate the software. They take a hands-off approach. They let companies design systems to work for them. It ...
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  • 22 Jun, 2017

    What is a Clinical Trial Feasibility Study?

    By Editor
    Clinical Trial Feasibility Studies means finding the right investigators and patients then determining costs. It is done to evealuate how the test could fail then decide to proceed or not to proceed. The project manager and trial sponsor take the lead. They look at the records of investigators and see if they are able to do ...
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  • 16 Jun, 2017

    What are the New Clinical Trial Technologies?

    By Editor
    Clinical Trial Project Managers are are not necessarily using the newest technologies in the marketplace. Microsoft Project is popular but it is twenty-years old. Inertia is the main reason for not switching to the new technologies. Most technologies require a learning curve and project managers are averse to doing it because it takes time to learn ...
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  • 13 Jun, 2017

    Why Do Clinical Trials Take So Long to Start?

    By Editor
    Clinical Trials take too long to start. The clinical trial managers may not start a trial from 6-9 months to even 12 months. This is more time than it should. Research has shown that many prescription drug companies accept inefficiency. The threshold is much too high for inefficiency. Many clinical trial tools are antiquated, such as decade-old ...
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