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A New Way of Authoring and Reviewing Documents for Clinical Development
Session Chair(s)
David Twomey
Decibel Therapeutics , United States
Historically, the clinical document writing process is error prone due to human error and its use of old technology, which does not integrate well with all the systems used in clinical trials. By automating and integrating clinical authoring, we improve both accuracy and efficiency, and leverage information across clinical business systems. The result is higher overall quality and consistency, more timely document authoring, and rapid knowledge sharing across departments. This session will describe how various companies have solved this problem. One solution was to create a cloud-based software solution for authoring, reviewing, and approving clinical trial documents. The Collaborative Authoring Tool (CAT) integrates many downstream systems to automate the transfer of content and enables the re-use of standard language to improve quality and consistency
Learning Objective : Describe custom software that facilitates the collaborative authoring, reviewing, and approval of clinical documents.
Speaker(s)
CASE Study: Collaborative Protocol Authoring with Tech-Enabled CPT and Reuse
Mitzi Allred, PhD
Merck & Co., Inc, United States
Director, Clinical Operations
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