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Volume 16 Issue 1
 
Agile/Scrum Adoption in Regulated Industries
Volume 7 Issue 1

Agile/Scrum Adoption in Regulated Industries

According to the 2013 State-of-Scrum Report, Agile/Scrum is being practiced in 33% of highly regulated industries like finance, healthcare, insurance and aerospace. T...
6 October 2015 Volume 7 Issue 1
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Get Back – Managing your Return Logistics for Clinical Trials
Editorial Archive

Get Back – Managing your Return Logistics for Clinical Trials

Over the last ten years, the way that the pharmaceutical industry is expected to deliver new drug products to market has seen symbolic change. This shift in process h...
9 February 2015 Editorial Archive | Logistics V7 I1 | Volume 7 Issue 1
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Mobile ePRO as a Cost-effective Method of Patient Data Capture
Editorial Archive

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

As digital technology plays an increasingly important part in our everyday lives, it comes as no surprise that it has a huge potential to address some of the key chal...
9 February 2015 Editorial Archive | Technology V7 I1 | Volume 7 Issue 1
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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

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

Clinical trials are the experimental foundation on which modern medicine is built. Human medicines cannot be sold without permission from a licensing authority, and p...
9 February 2015 Editorial Archive | Technology V7 I1 | Volume 7 Issue 1
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Understanding the Importance of Mobile Health for Pharma
Editorial Archive

Understanding the Importance of Mobile Health for Pharma

Mobile health (mHealth) may be the buzzword of today, but unlike many other buzzwords, this one will not be just another flash in the pan. Mobile health offers the li...
9 February 2015 Editorial Archive | Technology V7 I1 | Volume 7 Issue 1
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Pyoderma Gangrenosum: A Systemic Review of the Incidence and Prevalence
Editorial Archive

Pyoderma Gangrenosum: A Systemic Review of the Incidence and Prevalence

Pyoderma gangrenosum (PG) is a rare and serious skin disease in which a painful nodule breaks down to form progressive enlarging ulcers, and leads to a severe and sig...
9 February 2015 Editorial Archive | Therapeutics V7 I1 | Volume 7 Issue 1
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Comparison of Marketing Authorisation and its Requirements for Brunei Darussalam and Indonesia
Editorial Archive

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

The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries of the world vary from each other. ...
9 February 2015 Editorial Archive | Market Report V7 I1 | Volume 7 Issue 1
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Centralised Monitoring: A Smart and Cost-efficient Approach
Editorial Archive

Centralised Monitoring: A Smart and Cost-efficient Approach

The clinical monitoring cost is one of the major costs and accounts for one-third of the overall cost of clinical trial management. As the complexities in clinical tr...
9 February 2015 Editorial Archive | Regulatory V7 I1 | Volume 7 Issue 1
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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

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

The year 2015 marks the 10th anniversary of the release of two ICH Harmonised Tripartite Guidelines that have governed the cardiac safety regulatory landscape, more s...
9 February 2015 Editorial Archive | Regulatory V7 I1 | Volume 7 Issue 1
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Overcoming Regulatory Challenges in Cognitive Drug Development
Editorial Archive

Overcoming Regulatory Challenges in Cognitive Drug Development

In recent years, numerous pharmaceutical and biotechnology companies have undertaken development programmes intended to assess the efficacy of various pro-cognitive d...
9 February 2015 Editorial Archive | Regulatory V7 I1 | Volume 7 Issue 1
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