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Volume 16 Issue 2
 
Closing the Gap: A Hopeful Outlook for Paediatric Medical Devices
Volume 10 Issue 6

Closing the Gap: A Hopeful Outlook for Paediatric Medical Devices

The disparity between the availability of medical devices for paediatric and adult patients has recently sparked regulatory, academic, scientific, and economic debate...
10 December 2018 Volume 10 Issue 6
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Artificial Intelligence in Life Sciences – How Far Can it Go?
Volume 10 Issue 6

Artificial Intelligence in Life Sciences – How Far Can it Go?

AI, or artificial intelligence, is one of the most hyped terms to emerge in technology over the past decade. Despite that hype, it does possess the potential to truly...
10 December 2018 Volume 10 Issue 6
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eSource to SDTM: End-to-end Automation
Volume 10 Issue 6

eSource to SDTM: End-to-end Automation

The data generated during the development of new medicines come in a wide range of formats and may be generated from a variety of sources. Collecting, verifying and m...
10 December 2018 Volume 10 Issue 6
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The Value of Patient Advocacy Groups in Rare Disease Development: A Path to Strong Patient Engagement
Volume 10 Issue 6

The Value of Patient Advocacy Groups in Rare Disease Development: A Path to Strong Patient Engagement

Clinical trials in therapeutic areas targeting rare diseases are riddled with operational difficulties, with patient recruitment being arguably the most challenging a...
10 December 2018 Volume 10 Issue 6
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FAERS Deconstructed: Requirements, Opportunities, and Limitations of the FDA’s Public Adverse Event Reports
Volume 10 Issue 6

FAERS Deconstructed: Requirements, Opportunities, and Limitations of the FDA’s Public Adverse Event Reports

Not all possible side-effects of a pharmaceutical drug or medical device can be anticipated based merely on preapproval studies. The FDA Office of Surveillance and Ep...
10 December 2018 Volume 10 Issue 6
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Five Best Practices for Taming the Global Clinical Trial Beast
Volume 10 Issue 6

Five Best Practices for Taming the Global Clinical Trial Beast

All clinical trials come with inherent challenges. Sponsors must navigate an intricate web of regulatory issues, approval time frames,  operational complexities, and ...
10 December 2018 Volume 10 Issue 6
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The EU Clinical Trials Regulation: Moving from Assent to Consent
Volume 10 Issue 6

The EU Clinical Trials Regulation: Moving from Assent to Consent

The EU Clinical Trials Regulation must be implemented directly into the law in the EU Member States, whilst Directives, such as the EU Clinical Trials Directive (CTD)...
10 December 2018 Volume 10 Issue 6
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Are Priority Review Vouchers the Incentive FDA Intended?
Volume 10 Issue 6

Are Priority Review Vouchers the Incentive FDA Intended?

When the US Congress authorised the FDA’s Tropical Disease Priority Review Voucher Program in 2007, it sought to spur development of drugs that prevent or treat tropi...
10 December 2018 Volume 10 Issue 6
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Speed, Quality and Cost – Leveraging Australia to Expedite Clinical Development
Volume 10 Issue 6

Speed, Quality and Cost – Leveraging Australia to Expedite Clinical Development

In recent years, the pharmaceutical industry has seen tremendous changes in the way it is expected to deliver new drugs to market: being under increasing pressure to ...
10 December 2018 Volume 10 Issue 6
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Organising and Conducting Clinical Trials of Medical Devices
Volume 10 Issue 6

Organising and Conducting Clinical Trials of Medical Devices

Rossen Mihaylov, Ramus Medical explores how to organise CT on medical devices in order for the sponsor and CRO to be able to operate as a team and in line with the ne...
10 December 2018 Volume 10 Issue 6
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