Ethical GmbH Adds Artificial Intelligence to SAE Data Reconciliation Automation

Ethical GmbH releases a new version of eReconciliation® that uses artificial intelligence (AI) to improve the performance of the software automation engine. This third version of eReconciliation® continues to optimize time spent on SAE data reconciliation and reduce the risk of errors and omissions, particularly when high volumes of data or heterogeneous environments are involved.

Ethical GmbH Adds Artificial Intelligence to SAE Data Reconciliation Automation

Ethical GmbH, a Swiss eClinical company providing cost-effective, compliant software and customized support to simplify the daily work of clinical teams, is releasing an improved version of eReconciliation®. By adding artificial intelligence to the software automation engine, this third version of eReconciliation® aims to further reduce the burden associated with safety data reconciliation and continue to strengthen the quality of safety data.

Automated SAE data reconciliation saves time and supports data quality

eReconciliation® v1.0 was released in 2019 as a cloud system to support the manual review of SAE data but the first use, on premises, dates to 2011. The software displays on the same screen SAE data from the safety and clinical datasets so that the user can easily compare records, match them when data is consistent, or follow-up on discrepancies. An improved second version was released in 2021 with an automation engine able to detect and match identical text strings. The automation engine matches SAE data based on a score level and the unmatched SAEs are flagged for review by a human user.

Manual review outputs feed and train the automation engine

The new eReconciliation® software version with added artificial intelligence allows to detect matches that cannot be found based on text strings comparison. Outputs of the manual review performed on remainder records are used to teach the AI algorithm. Each manual review feeds the algorithm with new information, gradually fine-tuning the engine capabilities.

A powerful solution for high volumes of data and heterogeneous environments

The algorithm is trained as needed by each customer, for example with information from the study or therapeutic area, or from matching keywords. Each customer company decides the matching score appropriate to their situation. The matching score increases as the algorithm performance improves. Users save more time as study progresses and database lock approaches. SAE data reconciliation automation powered by artificial Intelligence is particularly fit for long studies with high volumes of data or companies like CROs working with heterogeneous data environments.

Mimmo Garibbo, Director of Ethical GmbH stated: "We are proud of our innovative eReconciliation® software that has already helped teams around the world reduce time spent reconciling safety data while strengthening their trial data quality. With the automation engine and artificial intelligence, we now turn to customers who deal with high volumes of safety data or work with heterogeneous environments. For each customer, sponsor, ARO or CRO, we set up a process that supports their organization and configure automation in accordance with their data environment."

eReconciliation® is a highly automatable software and customized support solution for SAE data reconciliation. Equipped with smart tools, hands-on task management features and a secured audit trail, eReconciliation® allows data management, clinical and safety teams to perform SAE data reconciliation all along the study with minimum burden, simplifying operations management, supporting data quality and guaranteeing GxP compliance.

Media Contact:

Mimmo Garibbo, Director of Ethical GmbH
E-Mail: mimmo.garibbo@ethical.ch
www.ethicalclinical.com

Source: Ethical GmbH

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Categories: Healthcare Insurance

Tags: AI, artificial intelligence, automation, clinical trials, reconciliation, SAE, sae reconciliation


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Clinical and Endpoint Adjudication, Protocol Deviations, Data and Safety Monitoring Boards and Data Monitoring Committees Management on cost-effective, compliant software solutions for over 16 years.

Ethical GmbH - Clinical Committee Trusted Experts
Wartenbergstrasse 40
Basel, Other CH-4052
Switzerland