Target Health Blog

New Publication on Risk-based Monitoring

January 21, 2019

What's New

Target Health, “Champions of the Paperless Clinical Trial“™, is committed to effective and efficient 21st century clinical trials, where digital records replace the paper records of the past. And yes, we always “do what we say“.

A new paper, entitled “Query Effectiveness in Light of Risk-based Monitoring (RBM),“ was just published in Data Basics (Winter 2018). The co-authors are Imogene McCanless Dunn (vTv Therapeutics); Michelle Nusser-Meany (Mutare Lifesciences) and Vadim Tantsyura, Yong Joong Kim, Timothy Cho and Jules Mitchel (Target Health Inc.). The publication uses data derived from a study where direct data entry at the time of the patient encounter occurred. And as icing on the cake, the product was recently approved by FDA.

The following is abstracted from the paper:

Query management within a clinical trial is a standardized process utilized by data management and clinical operations. The resources and costs associated with query management are not trivial, as querying is a long, multi-step process that involves many individuals and sites. Unfortunately, multitudes of queries that have no impact on the study performance or conclusion, which then inflates the overall cost of studies, is commonplace. In order to reduce costs and improve efficiencies, the question can be asked as to whether an “effective“ query be differentiated from a “noneffective“ query? The Query Effectiveness Ratio (QER), defined as the ratio of the number of queries leading to change divided by the total number of queries issued may be such a solution.

For more information about Target Health, contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors.

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

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