Patient Data Reporting Featured Articles

71. An Insider's Guide To Interactive Response Technology (IRT) For Clinical Trials 4/4/2019

    During a study startup phase, interactive response technology (IRT) system development can be difficult for clinical teams to navigate successfully, especially when team members have limited experience building or using the technology. An experienced project manager shares some lessons he has learned to empower clinical team members to make better decisions when it comes to this crucial technology and in the end develop better and safer systems.

72. eTMF: A Paperless Paradise … Or Paradise Lost? 3/28/2019

    The quest to eliminate paper, both outside and within clinical research, is filled with ironic and unexpected consequences. Consider Amazon, a tech leader with a market capitalization today of more than $800 billion dollars. The company was founded in 1994 as an online retailer of physical paper books, but in 2007, i.t launched the Kindle e-reader to eliminate the need for bulky, heavy, dusty, old-fashioned tomes.

73. Use eTMF To Navigate FDA Inspections 1/31/2019

    “Being inspection-ready means making sure the TMF is up to speed,” says Brent Sorrells, director of clinical operations for Allakos. “During a preapproval inspection in 2015, we learned quite a few things. The FDA inspector followed the BIMO guidance to a T. One of the primary things I learned is that we were not as organized as we had thought, even though we had done a dry run of an inspection after our NDA filing.”

74. Otsuka: Real-Time Data Changes Trial Paradigm 1/29/2019

    As the Otsuka VP of Applied Innovation and Process Improvement, Debbie Profit spends a lot of her time thinking about the future of clinical trials. “There are changes occurring in the industry that will force clinical development executives to shift their mindset,” says Profit. “I am trying to understand what clinical trial sites will look like going forward.”

75. Measuring The Financial Impact Of Remote (Digital) Clinical Trials 1/29/2019

    Many companies are exploring ways to continue to innovate and bring novel drugs to patients while reducing the overall costs of drug development process. Enter… remote clinical trials.

76. What Skills Are Needed To Effectively Manage An eTMF? 1/22/2019

    To date, one critical SME has been left out when adopting an eTMF, whether it’s outsourced to a CRO to manage, outsourced to a third-party vendor, or maintained and managed in house at the sponsor (or some combination thereof — which is an article for another day!). Can you guess who that SME is?

77. Sites Need Technology, Infrastructure Investments To Improve Clinical Trials 11/29/2018

    Our industry is unintentionally discouraging clinical research sites from investing in infrastructure. As a generalization, sites have the fewest resources of all the stakeholders involved in the successful execution of a clinical research trial. Most sites are very small and struggle to break even. Most sites have little to no IT infrastructure and can’t afford to build it. Most sites have staffing models where employees and physicians have too many disparate roles and responsibilities without the support or training to be successful. Employees are shared between research and non-research functions. The thin operating margins limit sites’ ability to build a meaningful, robust infrastructure, and this limits sites’ ability to be profitable.

78. Virtual Registries: How To Bring Patient-Centricity Into Clinical Research 11/27/2018

    Our rapidly increasing genetic-level disease knowledge and exponential technology advances are changing the way we manage health. But we may never fully seize these opportunities if we limit our clinical research approach to past models. Changing societal attitudes around sharing personal data and new consumer technology make innovative study designs and operations possible. This includes new possibilities in designing and operationalizing patient registries by moving to “virtual” setups.

79. Blame Shouldn't Be Filed In The TMF: A Call For Trial Master File Process Improvement 10/23/2018

    “A bad system will beat a good person every time.”¹ This quote by legendary management thinker W. Edwards Deming introduces the fundamental concept underlying process thinking. Process thinking, as the name implies, is a human factors-derived philosophy concerned with viewing the world through a process-oriented perspective. Processes are the essential components of our systems that enable them to execute their purpose: any set of steps designed to achieve an objective can be considered a process. The wide scope of this definition reflects the abundance of processes in all areas of our lives – both inside and outside the workplace. Based on this definition, a process is an objective-driven task.

80. Digital Data Flow: From A Common Protocol Template To True Digital Automation 8/21/2018

    The biopharma industry is on the verge of moving from a highly manual document-based approach to study design, study planning, and data collection to one that can rely on currently available technology for the purposes of realizing both efficiency and improving quality.