Our Publications

As a science-driven company, we proudly publish numerous scientific papers every year in high-impact journals. Please feel free to contact our Science-team if you have questions or comments to our publications, or proposals for new scientific collaborations: science@nbcd.com

2 publications found

January 04, 2016
Monitoring is a costly requirement when conducting clinical trials. New regulatory guidance encourages the industry to consider alternative monitoring methods to the traditional 100 % source data verification (SDV) approach. The purpose of this literature review is to provide an overview of publications on different monitoring methods and their impact on subject safety data, data integrity, and monitoring cost.

Clinical Data Quality
October 19, 2014
The aim of this project was to perform an empirical evaluation of the impact of on site source data verification (SDV) on the data quality in a clinical trial database to guide an informed decision on selection of the monitoring approach. We used data from three randomized phase III trials monitored with a combination of complete SDV or partial SDV. After database lock, individual subject data were extracted from the clinical database and subjected to post hoc complete SDV. Error rates were calculated with focus on the degree of on study monitoring and relevance and analyzed for potential impact on end points.

Clinical Data Quality