Target Health Resources

Data Management

Impact on Data Management of the New Definitions of Data Quality

December 1, 2016

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Data Management
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Article

Risk-based approaches to monitoring (RBM) in clinical research1, 2, characterized by more cerebral operations with focus on critical processes and data components, are growing in popularity.

New Definitions of Data Quality

Impact on Data Management of the New Definitions of Data Quality (DQ), Risk-based Approaches to Quality and eSource Methodologies

Product Using Direct Data Entry Receives FDA Marketing Clearance

December 11, 2015

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Data Management
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News

The FDA has cleared for marketing a medical cooling device from Lund, Sweden­based Dignitana. Digitana engaged Target Health as its CRO, using its web-based eSource-enable EDC system to collect direct data entry from patients. According to Target Health, this is the first product to be approved using in its pivotal trial, direct data entry of patient data at the time of the clinic visit into an EDC system, with no need for paper records.

How Risk-Based Monitoring and eSource Methodologies are Impacting Clinical Sites, Patients, Regulators and Sponsors

Dr. Jules Mitchel, President of Target Health, speaks at DIA 2015 in Washington DC.

Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality

This article proposes a practical risk-based monitoring approach based on published statistical evidence addressing the impact of database changes subsequent to Source Document Verification (SDV).

eSource Records in Clinical Research: Keeping it Simple

April 15, 2015

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Data Management
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Article

The benefits of eSource data: collecting data digitally without having to record the data on a piece of paper first.

Impact of Risk-Based Monitoring and eSource Methodologies on Clinical Sites, Patients, Regulators and Sponsors

From CBI Conference, March 2015: Impact of Risk-Based Monitoring and eSource Methodologies on Clinical Sites, Patients, Regulators and Sponsors

Dr. Jules Mitchel - Viewpoint on Data Management

September 1, 2014

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Data Management
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News

When original data are captured through validated electronic systems, there is no need to perform source document verification (SDV)> The key to regulatory compliance becomes the availability of validated, independent, contemporaneous copies of source records.

How to Efficiently and Effectively Balance Central Monitoring with On-Site Monitoring

Experience from Phase 3 Study Using Risk-Based Monitoring and eSource