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

1 publication found

December 07, 2022

Impact of Monitoring Approaches on Data Quality in Clinical Trials

Source Data Verification (SDV) has been reported to account for up to 25% of the budget in Clinical Trials (CT) and cost-benefit of SDV has been questioned. Guidelines for Risk-Based Monitoring (RBM) were published in 2013 by agencies and in 2016, ICH-GCP-E6-(R2) added a requirement for risk-based approaches. This report will perform a comparison of the impact of RBM versus Classic Monitoring (CM) on data quality (defined as accuracy of data reporting from source data to final trial data) and expected impact on costs of CTs.

Journals:

British Journal of Clinical Pharmacology

Authors:

Andersen JR , Sehested CV , Byrjalsen I , Follin AB , Bihlet AR

Clinical Data Quality