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SCDM 2022 Annual Conference - Data Analytics: Protecting Data Integrity, Endpoints and Patient Safety

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CONFERENCE PRESENTATION · September 14, 2022
Data Analytics - Protecting Data Integrity, Endpoints and Patient Safety
  • Session Type: Roundtable
  • Topic: RB-CDM + Data Integrity
  • Session Level: Advanced
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Overview
In this session we will focus on harnessing and leveraging the power of the data to create proactive, actionable insights to ensure three main areas of focus: protecting data integrity, patient safety and study endpoints. We will dive deep into analytics, how to embed Data Science within your processes, most appropriate way to view the data, innovative data review approaches when working in a reduced SDV model and what analytics to apply to your various data sources.

A secondary piece to this sessions is a further understanding of your players, how to capitalize on the skill-sets of your resources; where should these players be positioned within your company to ensure successful execution of data analytics across various functions, considering data access, data ingestion and technology.
What You'll Learn
  • In this session learner will further develop their understanding of technology used in industry to support risk based monitoring.
  • Learners will understand the analytics behind the data to support a reduction in SDV couple with how to view and dissect their data to give them actionable insights.
  • Learners will gain an understanding of processes associated with data science in data management and how to leverage the skill-sets of the employees assigned to the study.
  • Learners will be able to apply analytics to ensure patient safety, endpoint protection and data integrity remain at the forefront of the analytics designed and applied.
Meet the Presenters
Lynn Demings
Associate Director, Clinical Data Management
Icon Plc
Regionally based in Victoria, British Columbia, Canada, Lynn has over twenty years of clinical research experience, including 9 years in the evolving space of Risk Based Monitoring and Data Science. In her current role, Director, Data Management, Lynn is responsible client oversight as well as hiring, onboarding and overseeing regionally based Clinical Data Scientists Leads who assess trial compliance by participating in upfront risk assessment and performing trend analysis, exploratory data reviews and reporting risk associated with the data to internal and external stakeholders. Lynn has been instrumental in developing and evolving the global Central Monitoring activities and serves on many cross-functional initiatives to drive process and technology enhancements.
Thomas Wegman
BMS
Tom has thirty years of broad global clinical development experience, encompassing statistics, clinical operations, data science / analytics and CRO business development / account management. He is acknowledged by colleagues for the ability to work with all departmental functions, and across many different cultures. Tom is presently focused on applying data science methodologies to improving lupus and Sjögren’s disease trial management.
Japie Van Tonder
Chief Data Scientist
NuvoteQ
Olgica Klindworth
Sr. Director, R&D
Medidata
Olgica Klindworth is a Senior Director, Product Development at Medidata focusing on development of Data Management and Centralized statistical monitoring technologies. Prior to joining Medidata in Aug, 2021, Olgica spent 17 years at PPD, Inc. leading Data Management teams, building Data Management capabilities and overseeing execution of a number of clinical trials across various therapeutic areas. Since 2014, Ms. Klindworth spearheaded development of the Data Analytics and Centralized Monitoring team and capabilities at PPD. Olgica received her Bachelor of Science in Microbiology from University of Texas at Austin and Master of Science in Analytics from Texas A&M University.
Earn CEUs
SCDM is authorized by IACET to offer 0.2 CEUs for this education program. Participants are eligible to receive CEUs upon successful completion of the digital assessment questionnaire linked to this session, within 30 days after the purchase of the conference session.

Price
SCDM members: $50
Non-members: $175

Not yet an SCDM member? Purchase this conference session and get a one-year membership with SCDM on us to enjoy all our educational programs and sessions at a discounted price.
Need support?
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General support:
The SCDM Learning team is here to help. Contact us at learning@scdm.org or call +32 232 024 87.