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Journal for Clinical Studies
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Category Archives: Volume 9 Issue 2

In Pursuit of eConsent: Best Practice Recommendations for Successful Integration

Editorial Archive, Volume 9 Issue 2By flabio510th April 2017

Electronic informed consent (eConsent) solutions have been introduced in recent years, representing a major advancement in improving information delivery to…

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Clinical Development in Challenging Cancers: Adrenocortical Carcinoma

Editorial Archive, Volume 9 Issue 2By flabio510th April 2017

Adrenocortical carcinoma (ACC) is a rare cancer with an estimated incidence of 1 to 2 patients per million people annually.…

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Companies Need More Awareness of EU Pediatric Investigation Plans (PIPs)

Editorial Archive, Volume 9 Issue 2By flabio510th April 2017

Pediatric legislation was introduced based on the American Academy of Pediatrics (AAP) concerns that children did not participate sufficiently in…

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Constructing Composites to Optimise Cognitive Outcomes

Editorial Archive, Volume 9 Issue 2By flabio510th April 2017

Henry J. Riordan, Ph.D., Executive Vice President of Medical and Scientific Affairs and Global Lead for Neuroscience at Worldwide Clinical…

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Clinical Trials in Central and Eastern Europe: Keeping Up with Global Competition

Editorial Archive, Volume 9 Issue 2By flabio510th April 2017

A great number of willing patients, highly experienced researchers and EMA-compliant legislation make the CEE region an attractive research site…

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Clinical Trial Enrolment in China: The Potential Role of Patient Advocacy Groups and Digital Health Networks

Editorial Archive, Volume 9 Issue 2By flabio510th April 2017

China has a large and vibrant ecosystem of patient advocacy groups and digital health networks that provides clinical trial sponsors…

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Risk-based Monitoring: The Innovative Model Redefining Clinical Trial Risk Management

Editorial Archive, Volume 9 Issue 2By flabio510th April 2017

One area in the clinical trial process that has been identified for improvement is risk-based planning and management. Monitoring and…

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CDISC for Non-Experts Everything You Always Wanted to Know About CDISC (But Were Afraid to Ask)

Editorial Archive, Volume 9 Issue 2By flabio510th April 2017

CDSIC is meant to enable you to collect, store and transfer clinical data in a way that makes them easily…

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The Challenges and Benefits of Biosimilar Drug Development for Trastuzumab, a Precision Medicine

Editorial Archive, Volume 9 Issue 2By flabio510th April 2017

Monoclonal antibodies (mAb) are among the most promising biologic drugs currently on the market for treatment of life-threatening diseases. The…

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Pharmacovigilance’s Growing Influence

Editorial Archive, Volume 9 Issue 2By flabio510th April 2017

Pharmacovigilance will always be about protecting patients. The discipline is rapidly evolving into something greater than regulatory compliance; increasingly, pharmacovigilance…

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