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Home / Data Reconciliation Blog

Ethical’s BLOG

Stay connected to eReconciliation® news
and SAE Data Reconciliation in the eClinical World

Ethical’s Director Mimmo Garibbo and colleagues in Quality Assurance, Software
Engineering and Security bring you news and insight on issues, trends, technology,
developments and noteworthy events in the world of Clinical Data Reconciliation

reconciliation AI

By Ethical 14 Jul, 2022

Ethical is adding AI to its eReconciliation automation engine

The English language gives the possibility to describe the same thing in many different ways and even the highly regulated coding dictionaries such as MedDRA and SNOMED are very flexible and allow multiple terms when it comes to describing adverse events, medical history or concomitant medication. Which of these terms are equivalent? Which can be c...

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Excel for Reconciliation

By Ethical 14 Jun, 2022

Do you really use excel to reconcile critical safety data for your studies?

Serious Adverse Events (SAE) reconciliation is a crucial step in the pharmacovigilance process not only because it improves the study data integrity and quality, but also because it is a requirement for ensuring patient safety. This is an important aspect that health authorities have in mind during inspections and the main reason why auditors look ...

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sae reconciliation automation

By Ethical 02 Nov, 2021

SAE data reconciliation automation: from convenience to necessity

Clinical research professionals are well aware that the parallel processing of SAEs in two different systems during the conduct of clinical trials, on one hand the clinical database and on the other the safety database, inevitably creates disparities that need to be resolved via a process of data reconciliation. Longer and more complex trials are m...

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drug safety reporting

By Ethical 07 Jun, 2021

Safety Data Reconciliation in Drug Safety Reporting: Can the Process be Omitted?

What is drug safety reporting exactly? Evidence based medicine requires efficacy and safety data collected in clinical trials to be of high quality. Complex procedures have been developed over the years to insure required quality level. In particular, safety signals must be monitored all along the development lifecycle in order to avoid exposing pa...

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