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Volume 16 Issue 1
 
How Changes in Practice are Changing Bleeding End Points in Coronary Interventional Trials
Editorial Archive

How Changes in Practice are Changing Bleeding End Points in Coronary Interventional Trials

Cardiac catheterisation and coronary intervention both require catheters to be placed into arteries - engendering risk. In their paper, L. Allen Kindman, Joshua Betch...
7 April 2014 Editorial Archive | Special Features V6 I2 | Volume 6 Issue 2
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Orphan Drugs: R&D Challenges with Updates from Turkey and Middle East Countries
Editorial Archive

Orphan Drugs: R&D Challenges with Updates from Turkey and Middle East Countries

Rare diseases (RDs) are an important public-health issue and a challenge for the medical community. They are called ‘health orphans’, as a result of being neglected f...
7 April 2014 Editorial Archive | Special Features V6 I2 | Volume 6 Issue 2
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Import of Investigational Medicinal Products into Israel
Editorial Archive

Import of Investigational Medicinal Products into Israel

Israel has a robust and growing pharmaceutical industry, particularly for biopharmaceuticals and advanced therapeutic medicinal products (ATMP). It is home to one of ...
7 April 2014 Editorial Archive | It & Logistics V6 I2 | Volume 6 Issue 2
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The Role of Mobile Technology in Reshaping the Pharmaceutical Industry
Editorial Archive

The Role of Mobile Technology in Reshaping the Pharmaceutical Industry

With the growth of mobile devices, healthcare professionals (HCPs) and the general public are accessing and collecting medical information via their smartphones. This...
7 April 2014 Editorial Archive | It & Logistics V6 I2 | Volume 6 Issue 2
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CNS Clinical Trials in Russia
Editorial Archive

CNS Clinical Trials in Russia

In Russia, most CNS clinical studies have been conducted in MS, epilepsy, AD, stroke, depression and schizophrenia. A number of leading Russian biopharmaceutical comp...
7 April 2014 Editorial Archive | Therapeutics V6 I2 | Volume 6 Issue 2
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New Standards in Alzheimer’s Disease Trial Design
Editorial Archive

New Standards in Alzheimer’s Disease Trial Design

Over the last decade, the only new treatment for Alzheimer’s to make it to market is memantine (Namenda™).  The number of failed drug programs in that span provides a...
7 April 2014 Editorial Archive | Therapeutics V6 I2 | Volume 6 Issue 2
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Patient-derived Xenograft (PDX) Model: An Evolution in Oncology Drug Study
Editorial Archive

Patient-derived Xenograft (PDX) Model: An Evolution in Oncology Drug Study

In order to address shortcomings at the discovery stage in oncology studies, PDX has recently emerged as the upcoming technique. Through the PDX model, original tumou...
7 April 2014 Editorial Archive | Therapeutics V6 I2 | Volume 6 Issue 2
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Risk-sharing: Supplementing Clinical Trials for Payer and HTA Success
Regulatory V6 I2

Risk-sharing: Supplementing Clinical Trials for Payer and HTA Success

As the benefits of real-world data become more apparent, so too, do issues around its appropriate collection methodology and reliability. Olivier Ethgen of SERFAN Inn...
7 April 2014 Regulatory V6 I2 | Volume 6 Issue 2
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Is Risk-based Monitoring an Appropriate Methodology for Clinical Trials in Emerging Regions?
Editorial Archive

Is Risk-based Monitoring an Appropriate Methodology for Clinical Trials in Emerging Regions?

When it comes to emerging regions - where sites and monitors generally have less experience in clinical research than those in North America and Western Europe, the c...
7 April 2014 Editorial Archive | Regulatory V6 I2 | Volume 6 Issue 2
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Regulatory Framework for Developing Clinical Trials in Romania
Editorial Archive

Regulatory Framework for Developing Clinical Trials in Romania

The measure of Romania’s success as a clinical trials destination lies in the rapid evolution of the regulatory framework, which was promptly transposed from EU rules...
7 April 2014 Editorial Archive | Regulatory V6 I2 | Volume 6 Issue 2
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