Garbage In - Garbage Out: The Critical Role of Data Quality in Clinical
Research

In this lecture, we shall explore the challenges posed to clinical research
(clinical trials, studies, and patient registries) by compromised data quality,
and the technical solutions developed to tackle them. The importance of
specialized user-friendly, real-time, regulatory-approved Electronic Data
Capture (EDC) systems, together with tailored data management processes, will be
discussed, emphasizing how software and algorithmic solutions can help ensure
data accuracy, reliability, and integrity. We shall showcase CLADE-IS, a unique
system for clinical data management ranging from databasing to the use of
ensemble learning, developed through in-house R&D at the Institute of
Biostatistics and Analyses, a Masaryk University spin-off.

CLADE-IS has been rigorously evaluated and recently approved by an international
auditing team, resulting in the awarding of the prestigious ECRIN certification
to the spinoff—the only certified data center in Central and Eastern Europe.
This certification, coupled with the system's proven usability and scalability,
has already positioned the spinoff as a strong partner in co-managing large
international clinical trials. Finally, we will delve into how CLADE-IS ensures
high data quality through a combination of processes like Data Reviews, Central
Statistical Monitoring, Risk-Based Monitoring, and Data Augmentation, supported
by a multidisciplinary team including data engineers, data scientists, data
managers, and data analysts.