Contact UsLinkedin
X
Open/Close overlay
SAE Reconciliation Open/Close sub menu
KNOWLEDGE BASE
Reconciliation RegulationsReconciliation GlossaryReconciliation HandbookReconciliation Checklist
OUR EXPERTISE
Endpoint AdjudicationProtocol DeviationsData Safety Monitoring Boards eReconciliation Software Open/Close sub menu
HOW WE HELP
Import & Compare SAE DatasetsAI Powered Records MatchingManage Reconciliation Operations With ActionsDetect and Manage SAE Data ChangesEnsure GxP Compliance with Audit Trail
WHO WE HELP
CRO-Safe Partnership Program Ethical eReconciliation for SAE Reconciliation eReconciliation® Download the Solution Description DOWNLOAD GxP Compliance Open/Close sub menu
GxP QUALITY AND VALIDATION
Certification ISO-IEC 27001Computer Software ValidationEU-GDPR Regulation Compliance About Us Open/Close sub menu
ABOUT
Contact Us Blog
BOOK A CALL

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...

MORE
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 ...

MORE
sae reconciliation misconceptions

By Ethical 01 Feb, 2022

Five misconceptions about SAE data reconciliation

Misconception 1: SAE data in the safety and the clinical databases come from the same source so they are identical  While patient records are unique for each individual study subject, serious adverse event (SAE) data are collected in a very different way during the safety and clinical processes. Clinical data are recorded in the case report f...

MORE
reasons for reconciliation

By Ethical 30 Nov, 2021

Five reasons for careful planning of SAE Data Reconciliation

During all clinical trials, safety data are collected following two parallel processes and stored in two separate repositories: the clinical database and the safety database. These two sources must be reconciled before the database lock to ensure completeness and consistency of the safety monitoring of the trial. SAE data reconciliation is a crucia...

MORE

Tags

Download Ethical eReconciliation for SAE Reconciliation Dossier

eReconciliation
 
®
Solution Description

DOWNLOAD NOW