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 …

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 …

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 …

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 …

Healthcare mergers and acquisitions have been the cause of extensive debate across the medical industry, calling into question the tools and scale necessary to thrive …

Improving experimental drug success rate and accelerating clinical development are top priorities for pharmaceutical and biotech companies. Careful and considered decision-making is essential early on …

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 …

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 …

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 …

With the recent advent of adeno-associated, virus-based gene therapy treatments, limb girdle muscular dystrophy (LGMD) is currently attracting the attention of the biopharmaceutical industry, especially …