Patient Data Reporting Featured Articles

71. 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.”

72. 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.”

73. 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?

74. 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.

75. 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.

76. 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.

77. 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.

78. Adverse Event Reporting On Social Media — What You Need To Know 7/17/2018

    Adverse events (a suspected reaction to the API or to the API in combination with prescribed medicines or environmental factors) are, naturally, a challenging situation for patients in a clinical trial and may, in rare cases, become severe or even fatal. For sponsors, contract research organizations (CROs), and logistics partners, early notification and accurate information is vital to understanding and responding to a suspected adverse event. What happens if the patient goes off protocol and turns to social media?

79. Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC 7/12/2018

    Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the trial master file (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not easily achieved. The failure to achieve an inspection-ready TMF continues to be an area of growing risk for the clinical research industry.

80. 6 Insights To Broaden Your Understanding Of Clinical Trial Data Management 6/7/2018

    In your opinion, what’s the No. 1 problem when it comes to clinical trials?