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ACDM19 Speaker Details

Joke De Wever

Joke De Wever

Business & Decision Life Sciences

Biography:

Joke De Wever has spent over 15 years in the drug development industry, working for a non-profit organization, big pharma and CRO. She has extensive experience across data management and people management. She started her career as clinical data manager working on international phase I to phase III oncology studies and worked also as training manager and clinical system project leader before moving to a management position at Business & Decision Life Sciences (BDLS) in Brussels.
Due to her background in clinical data management and systems she’s interested in data visualization because it will allow the clinical teams to take decisions quicker.
She’s married and has 2 daughters. She likes spending time with her family.


Title of Session: Data visualization in a risk-based approach to support decision making

Description of Session:

Nowadays it is particularly important to have a visualization of data to answer the challenges faced by data management and clinical operations. It is part of a risk-based approach that associates cost to quality.

In the presentation, we will show how visualization on data queries can be included in the risk management process and support decision making.

Visualization enables easy identification of the sites that are less responsive or the type of queries resulting in poor resolution. As a result, sponsors may decide to set-up intermediate milestones for queries resolution, organize remote or on-site monitoring visits, provide additional training on a specific part of the study protocol or on the Electronic Data Capture (EDC) system.

Moreover, using a standard structure (SDTM or sponsor-specific) for representing information about data queries allows pooling data from multiple studies using different EDC Systems and helps sponsors adjusting their selection of participating sites.

Learning Objectives:

Familiarize with a practical example of risk-based approach

Interpretation of visuals in daily work

Learn best practices on creation a queries dashboard

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