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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.

Benjamin Devriendt

Benjamin Devriendt

Business & Decision Life Sciences

Biography:

Benjamin obtained his master’s degree in Bioinformatics and Modelling in 2012. After attending trainings on the clinical world in 2013, he completed an internship as a Data Manager in a Belgian CRO. Benjamin joined Business & Decision Life Sciences’ CRO in 2014 as a Data Integration Specialist, mapping clinical data to CDISC Standard SDTM. He likes to be able to do everything, which allowed him to become a Clinical Database Administrator in 2015 working on designing and managing clinical databases, and later a Project Manager for the Data Standards team in 2016.

Since 2017, he helps developing business offers for the CRO in Data Governance and Data Visualization while maintaining his other responsibilities. In 2018, he attended Tableau trainings to be able to develop further the data visualization portfolio of the CRO and to add the Query Dashboard to its content. Aside from work, Benjamin also enjoys hiking, playing badminton, board games and pen and paper games.





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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