New Publication in ACT – Time to Change the Clinical Trial Monitoring Paradigm: Results from a Multicenter Clinical Trial Using a Quality by Design Methodology, Risk-Based Monitoring and Real-Time Direct Data Entry

 

Our most recent paper entitled, Time to Change the Clinical Trial Monitoring Paradigm: Results from a Multicenter Clinical Trial Using a Quality by Design Methodology, Risk-Based Monitoring and Real-Time Direct Data Entry has been published in Applied Clinical Trials. It is coauthored with an independent QA expert, Michael Hamrell and one of our clients. We have other publications in ACT which are linked for your reference.

 

In the Innovator’s Prescription by Christensen, Grossman and Hwang, the authors share a concept that in order to maximize efficiencies, it is a good idea to bring the solution close to the problem that needs to be solved. Our approach to direct data entry at the time of the office visit and using computing and statistical tools to assess protocol compliance is surely consistent with that hypothesis. Writing data down first on a piece of paper creates an unnecessary gap of both space and time between the patient encounter and the study database.

 

We now have ongoing or completed 12 studies using direct data entry coupled with risk-based monitoring under 9 INDs/IDEs, and more are planned for this year. In addition to the US, study sites have included Canada and SE Asia. We expect at least one regulatory marketing application in 2014 and one in 2015. We have met with FDA and Health Canada and have made a presentation of our approach to EMA.

 

ON TARGET is the newsletter of Target Health Inc., a NYC-based contract research organization (CRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services, including the paperless clinical trial, to the pharmaceutical and device industries.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Chief Editor of On Target

Jules Mitchel, Editor

Vanessa Hays, Editorial Contributor

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