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Wednesday, June 27 • 2:00pm - 3:00pm
#361: A New Way of Authoring and Reviewing Documents for Clinical Development

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-658-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

Describe custom software that facilitates the collaborative authoring, reviewing, and approval of clinical documents.


David Twomey


CASE Study: Collaborative Protocol Authoring with Tech-Enabled CPT and Reuse
Mitzi Allred, PhD

avatar for Mitzi Allred

Mitzi Allred

Director, Clinical Operations, Merck & Co., Inc., United States
Mitzi Allred is a Director at MSD where her focus is on Structured Content Management. She has over 20 years of experience in the biopharmaceutical industry in Regulatory & Clinical Operations. Mitzi uses process improvement through information design and structured content reuse... Read More →

David Twomey

Director, Scientific Informatics Systems, Novartis Institute for Biomedical Research
David Twomey leads a group within Novartis Institutes for Biomedical Research supporting Translational Sciences. David is a solutions-focused technology leader with 25 years history of building and leading game-changing projects to empower life sciences with the best technologies... Read More →

Wednesday June 27, 2018 2:00pm - 3:00pm EDT
Room 258C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session