ARTICLES BY THOMAS COCCIARDI
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![Pulling The Curtain]( "eClinical Systems Post-COVID: Have You Realized Your Digital Transformation?")
eClinical Systems Post-COVID: Have You Realized Your Digital Transformation?7/13/2021When the pandemic started to impact our communities, what happened next exemplified the commitment and passion of TMF professionals, clinical researchers, and the pharmaceutical industry as a whole. Now, as the U.S. is in a summer characterized less by COVID and more by time spent with family and friends, are we willing to face COVID’s hard lessons?
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![Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC]( "Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC")
Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC7/12/2018Achieving 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.
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.