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…
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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…
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…
IDMP at a Crossroads
Providing annual reviews on IDMP progress has proved painful in recent years because momentum has not always been where it…
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…
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…
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…
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…
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…
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…