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Journal for Clinical Studies
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Category Archives: Volume 7 Issue 1

Agile/Scrum Adoption in Regulated Industries

Volume 7 Issue 1By flabio56th October 2015

According to the 2013 State-of-Scrum Report, Agile/Scrum is being practiced in 33% of highly regulated industries like finance, healthcare, insurance…

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Get Back – Managing your Return Logistics for Clinical Trials

Editorial Archive, Logistics V7 I1, Volume 7 Issue 1By flabio59th February 2015

Over the last ten years, the way that the pharmaceutical industry is expected to deliver new drug products to market…

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Mobile ePRO as a Cost-effective Method of Patient Data Capture

Editorial Archive, Technology V7 I1, Volume 7 Issue 1By flabio59th February 2015

As digital technology plays an increasingly important part in our everyday lives, it comes as no surprise that it has…

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Can mHealth be thought of as the Default Solution for Accelerating Completion and Increasing Success Outcomes in Clinical Trials?

Editorial Archive, Technology V7 I1, Volume 7 Issue 1By flabio59th February 2015

Clinical trials are the experimental foundation on which modern medicine is built. Human medicines cannot be sold without permission from…

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Understanding the Importance of Mobile Health for Pharma

Editorial Archive, Technology V7 I1, Volume 7 Issue 1By flabio59th February 2015

Mobile health (mHealth) may be the buzzword of today, but unlike many other buzzwords, this one will not be just…

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Pyoderma Gangrenosum: A Systemic Review of the Incidence and Prevalence

Editorial Archive, Therapeutics V7 I1, Volume 7 Issue 1By flabio59th February 20151 Comment

Pyoderma gangrenosum (PG) is a rare and serious skin disease in which a painful nodule breaks down to form progressive…

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Comparison of Marketing Authorisation and its Requirements for Brunei Darussalam and Indonesia

Editorial Archive, Market Report V7 I1, Volume 7 Issue 1By flabio59th February 2015

The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries of…

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Centralised Monitoring: A Smart and Cost-efficient Approach

Editorial Archive, Regulatory V7 I1, Volume 7 Issue 1By flabio59th February 2015

The clinical monitoring cost is one of the major costs and accounts for one-third of the overall cost of clinical…

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Cardiac Safety Investigations 10 Years after ICH Guidance E14: – Evolving Industry and Regulatory Viewpoints on Evaluation of Proarrhythmic Risk during New Drug Development

Editorial Archive, Regulatory V7 I1, Volume 7 Issue 1By flabio59th February 2015

The year 2015 marks the 10th anniversary of the release of two ICH Harmonised Tripartite Guidelines that have governed the…

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Overcoming Regulatory Challenges in Cognitive Drug Development

Editorial Archive, Regulatory V7 I1, Volume 7 Issue 1By flabio59th February 2015

In recent years, numerous pharmaceutical and biotechnology companies have undertaken development programmes intended to assess the efficacy of various pro-cognitive…

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