Clinical Data Management Insights: Using Digital SoA to Solve Modern Clinical Trial Challenges

Featuring:  Angie Maurer, Vice President of Product, and Veronica Vu, CCDM®, Director, Clinical Data Management, Faro Health Inc. 

Abstract: The Schedule of Activities (SoA) in a clinical trial protocol document has historically always been just that — a list of all required activities, assessments and procedures for a clinical trial that can get misinterpreted if not clearly written. Other pertinent information about what is needed and how to collect these activities is often nested in various other sections of the protocol in order to document all relevant information without overloading the table in a document format. Actively streamlining and organizing this data becomes a critical part of clinical data management. 

Translating a clinical trial protocol document into each of the elements needed for study data capture in downstream systems takes months in the current way of working due to disparate data sources, manual workflows and lack of standardization. By bringing words and data together into a digitized, source-of-truth SoA, study teams can effectively balance the complexity of protocol design and enable seamless digital data flow to drastically reduce study build times from months down to days.

What You Will Learn:

  • Understand the essential components of a complete data management ecosystem
  • Understand how roles are changing to support today’s clinical trial data
  • Identify the need for automation in data-driven activities along with examples of how using an integrated technology platform for study design can facilitate the data management process
  • Identify digital transformation lessons learned and business outcomes from adopting a digitized clinical development platform

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