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

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.

Register for this webinar to learn more about optimizing clinical data management processes and how common problems impacting study data quality can be avoided by visualizing the real-time impact of trial design decisions in a digital SoA.

Speakers

Angie Maurer, Vice President of Product, Faro Health Inc.

Angie Maurer has over 20+ years of clinical research experience in the pharmaceutical, biotechnology, medical device and diagnostic industries worldwide. Prior to Faro Health, Angie worked with various companies from small start-ups to large companies providing expertise in Quality Risk Management (program and software development), GCP compliance, learning management, process development and improvement, management and oversight of drug/device development programs, clinical trial management and QA clinical audits. Angie is a highly regarded professional with progressive, successful experience in providing clinical quality and compliance solutions with a proven record of developing successful strategies and companies in the healthcare industry.

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Veronica Vu, CCDM®, Director, Clinical Data Management, Faro Health Inc.

Blending her experience in product development and clinical data science, Veronica Vu, CCDM® has dedicated the past several years of her career to building novel clinical trials software solutions to yield high quality clinical data. Veronica is currently head of clinical data management at Faro Health where she advises on the development of data driven software features and standardization. Previously, she was head of clinical data management for clinical studies platforms at Verily Life Sciences where she oversaw clinical data management for the company’s decentralized clinical trials and scaled the clinical data management team through SOP development, data flow design and implementation and close collaboration with engineering teams to solve her team’s biggest challenges.

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