There were numerous articles in November 2018 that covered a wide range of topical issues. Here are five of the best stories you might have missed… (Click the headline to finish reading the story)

The Stem Cell Emperor’s New Clothes

For some time now, the potential of the global stem cell clinical supply industry has been undermined by a human foible captured in a Hans Christian Andersen fairy tale in the 1800s. In The Emperor’s New Clothes, a foolish ruler, who is obsessed with his appearance, pays swindlers much of his town’s treasury to weave a promised remarkable new outfit for himself. The swindlers convince the emperor that the new fabric will be so finely woven that it will be invisible to anyone who is either stupid or unfit for his or her position.

How to Conduct a Diabetes Trial – Lessons Learned

Type 2 diabetes mellitus (T2DM) is increasingly causing alarm among epidemiologists and diabetologists around the world, according to the American Diabetes Association. Traditionally a lifestyle disease affecting Western populations, numerous epidemiological studies have shown that nearly all populations who adapt to more Westernized lifestyles, including plentiful food, reduced physical labor for work, increased life expectancy and avoidance of communicable infectious diseases are at increased risk for T2DM and its associated complications.1

To Outsource or Not to Outsource? That is the Question

As a small to medium-sized company, the decision regarding how to outsource your clinical trial activities requires a fully informed discussion of the pros and cons. A completely in-sourced model is not practical for a small to medium-sized company, given the challenges with a small clinical organization.

For most companies, the need for appropriate staffing levels based on the phase of the study, having the required expertise based on the region of the clinical trial, and cost, are the main drivers for outsourcing clinical trial activities.

Clinical Evaluation for Software as a Medical Device

When we talk about clinical evaluation of a medical device, we tend to think about a physical device like an implant or a syringe. But as we move more and more toward a digital era, we should also consider software that are classified as medical devices.

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Recently Apple informed us that its Apple Watch received FDA clearance for an algorithm that detects an irregular heart rhythm.

To get this marketing authorization, this product must be validated to prove that it works. The best way for that is to build your clinical evaluation. But how do you do that?

Let’s review together what is needed for a Software as a Medical Device (SaMD).

Approaching Clinical Trials Where the Air Hurts Your Face

With the rise of cellular therapies and individualized medicine, cold chain study management has become a common issue in the clinical trial setting. Let’s take a look at some of the issues surrounding trial material at -70C and colder. Ultra-low and cryogenic products are not new areas and there are already many great standards out there for you to use. If your material does not have unique requirements, then there’s no need to reinvent the wheel.