• 5 Narrative Elements That Will Reveal The Masterpiece In Your TMF

    In response to the increasing opacity of the trial master file (TMF), clinical trial decision makers have embraced quantitative metrics as a way of characterizing and understanding the health of a TMF. Quantitative metrics are easily generated through the reporting functionality of a modern electronic TMF (eTMF) and appear to add value by leveraging the data passively generated through modern clinical applications. Although helpful to address specific concerns, especially those related to completeness, these metrics are often unintuitive and do not readily describe the aspects of a clinical trial most instrumental for TMF health.

  • Email/Excel vs. Clinical Applications: What Do ClinOps Professionals Really Need?

    The Veeva 2019 Unified Clinical Operations Survey examines the extent to which the clinical trial industry has sought to overcome its dependence on outmoded processes through the implementation of clinical applications. The survey’s main objective is to grow understanding of the “drivers, barriers, and benefits of a unified clinical operating model” through the exploration of clinical stakeholders’ attitudes about the clinical applications they currently use.

  • eTMF: A Paperless Paradise … Or Paradise Lost?

    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.

  • Blame Shouldn’t Be Filed In The TMF: A Call For Trial Master File Process Improvement

    “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.

  • Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC

    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.

  • Bridging The ISF-TMF Divide: What Roles Should Sponsors & Investigators Play?

    Regulation, more than just stipulating what must be done, must also define whose job it is to complete the task. The assignment of responsibility within the regulatory framework surrounding the clinical trial is essential to protecting the well-being of subjects and the validity of the trial’s data. Clear demarcation of the primary roles of sponsor and investigator and their associated responsibilities ensures that those conducting a trial are qualified and enables regulators to hold individuals and industry accountable to the high standards of ethical research.

  • Fear, Indecision, And The Memo To File

    How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself?


Thomas Cocciardi

Thomas Cocciardi is a technical writer at LMK Clinical Research Consulting who is committed to expressing the human story behind each trial master file (TMF). In addition to technical writing, he also works as a TMF health specialist for a large CRO. Before specializing in the TMF, Cocciardi gained wide-ranging experience, both in and out of the pharmaceutical industry, working as a clinical research coordinator, preclinical data coordinator, intern medical writer, and intern brand writer. He holds an M.S. in regulatory affairs for drugs, biologics, and medical devices from Northeastern University.