On-Demand Online Seminar: 
"Audit trail review in clinical studies using visual data analytics"

Insights from Sascha Heckermann, CEO at Profil:

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You will benefit by learning about: 

  • An overview of how to implement an audit trail review process
  • Data integrity in clinical research
  • Visual data analytic tools

Online Seminar synopsis

For the last few years, one of the hottest topics in clinical research has been data integrity. An important part of ensuring data integrity - that is now mandated by the authorities - is the structured review of audit trails. Unfortunately, there is a little guidance on how to perform the review. As it is virtually impossible to read through all lines in an audit trail (and it would not make much sense either), other means of review need to be applied.

In this online seminar we will show you how visual data analytic tools like Tableau can be used to dig into the audit trails to look for inconsistencies, deviations from procedures and possible fraud. In addition to this, we will show how to prepare your data using KNIME in order to make it accessible by your visualisation tools.

While this online seminar will focus on GCP the information presented can be used all across the GxP area. It is intended for everybody who is involved in the audit trail review process. 

Meet the presenter

Looking at clinical research from an IT perspective Sascha Heckermann joined Profil more than 20 years ago. Since then, Sascha has helped transform Profil into a CRO with a deep technical focus by implementing a software development department that has created numerous tools including its own EDC system.

In addition, information security is an important topic on his agenda that has led to a successful ISO 27001 certification in 2019.


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