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Volume 16 Issue 2
 
The Digital Twin in Clinical Research
Volume 12 Issue 1

The Digital Twin in Clinical Research

Digital twins of assets and processes are established by using Internet of Things (IoT) technology to acquire massive amounts of data in real time. On the other hand...
17 April 2020 Volume 12 Issue 1
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Boosting Trial Success through Blinded Data Analytics: What Can We Learn from CNS?
Volume 12 Issue 1

Boosting Trial Success through Blinded Data Analytics: What Can We Learn from CNS?

Research scientists know that data alone does not lie – but data can mislead. That’s especially true in clinical trials that rely on subjective endpoints to assess d...
20 February 2020 Volume 12 Issue 1
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FDA Guidance on Less Common Viral Hepatitis Type
Volume 12 Issue 1

FDA Guidance on Less Common Viral Hepatitis Type

The US Food and Drug Administration (FDA) recently revisited the topic of drugs for liver infection through a newly issued guidance document on hepatitis D virus (HD...
20 February 2020 Volume 12 Issue 1
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IDMP at a Crossroads
Volume 12 Issue 1

IDMP at a Crossroads

Providing annual reviews on IDMP progress has proved painful in recent years because momentum has not always been where it should be, due to shifting timescales and ...
20 February 2020 Volume 12 Issue 1
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Merger and Acquisition in Healthcare
Volume 12 Issue 1

Merger and Acquisition in Healthcare

Healthcare mergers and acquisitions have been the cause of extensive debate across the medical industry, calling into question the tools and scale necessary to thriv...
20 February 2020 Volume 12 Issue 1
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The Use of Modelling and Simulation Studies in Early-phase Clinical Trials
Volume 12 Issue 1

The Use of Modelling and Simulation Studies in Early-phase Clinical Trials

Improving experimental drug success rate and accelerating clinical development are top priorities for pharmaceutical and biotech companies. Careful and considered de...
20 February 2020 Volume 12 Issue 1
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The Biggest Regulatory Moments of 2019 & How They’ll Impact 2020
Volume 12 Issue 1

The Biggest Regulatory Moments of 2019 & How They’ll Impact 2020

2019 saw many noteworthy changes in the regulatory industry. In April 2019 it was announced that the FDA’s Office of New Drugs (OND) would create enhanced review zon...
20 February 2020 Volume 12 Issue 1
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Rescue Trials – When Should You Call for Help?
Volume 12 Issue 1

Rescue Trials – When Should You Call for Help?

Although previously very rare, more and more trials are becoming in need of 'rescue' as competition for resources means less experienced staff are left to manage unf...
20 February 2020 Volume 12 Issue 1
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Ensuring Effective Financial Management in Sponsored Research in Malaysia
Volume 12 Issue 1

Ensuring Effective Financial Management in Sponsored Research in Malaysia

A critical part of managing clinical trials is a solid, well thought out clinical trial budget. A successful budget to ensure a good quality clinical trial should no...
20 February 2020 Volume 12 Issue 1
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Exploring the Limb Girdle Muscular Dystrophy Clinical Trial Landscape
Volume 12 Issue 1

Exploring the Limb Girdle Muscular Dystrophy Clinical Trial Landscape

With the recent advent of adeno-associated, virus-based gene therapy treatments, limb girdle muscular dystrophy (LGMD) is currently attracting the attention of the b...
20 February 2020 Volume 12 Issue 1
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