Target Health Resources

Article

Regulatory Considerations when Designing and Running 21st Century Paperless Clinical Trials

February 15, 2017

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CRO
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Article

The regulatory push to the paperless clinical trial has occurred despite a pharmaceutical industry that has been risk-averse in adopting modern-day technology tools that could support clinical trials.

The Electronic Informed Consent Has Arrived

February 15, 2017

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CRO
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Article

The following are points to consider when designing and using an electronic informed consent form (eICF)

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

A Study of the Economic Impact and ROI of the Paperless Trial Master File (TMF or eTMF)

October 30, 2015

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Software
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Article

The economic impact of using a paperless trial master file (TMF or eTMF) in a 80-center study in ulcerative colitis.

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.

Lessons Learned From Direct Data Entry

July 4, 2012

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CRO
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Article

Lessons Learned From a Direct Data Entry Phase 2 Clinical Trial Under a US Investigational New Drug Application

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