How many of us drive to work every day? How many of us know the route so instinctively that we no longer think about where we have to go? It’s easy, right?
If you are like most small biotech companies, your budget is small and your timelines are as tight as possible in order to get the data needed to support the next round of funding and take the next step in your clinical development program. The best insurance you can use to achieve that next step and end up with a high-quality study that will pass an audit or inspection is proper planning ahead. This article will focus on proper resourcing of a sponsor’s internal clinical operations (ClinOps) team to adequately support a clinical trial during study startup.
Our global digital population — people around the world that are active internet users — has grown to 4.3 billion as of July 2019, representing roughly 56 percent of the global population. Of this global digital population, almost 4 billion are accessing the internet using mobile devices, with non-tablet mobile devices contributing nearly half of web page views worldwide.
The Veeva 2019 Unified Clinical Operations Survey examines the extent to which the clinical trial industry has sought to overcome its dependence on outmoded processes through the implementation of clinical applications. The survey’s main objective is to grow understanding of the “drivers, barriers, and benefits of a unified clinical operating model” through the exploration of clinical stakeholders’ attitudes about the clinical applications they currently use.
Have you ever put off doing something you knew needed to be done, even though you had the ability and money for it? Think exercising, getting a will or going to the dentist (hopefully you have dealt with at least the latter). In the same way, many study sponsors put off aggregating and utilizing key intelligence on their previously used investigator sites for use in future strategic site selections. At times, there will be unique reasons for engaging with a certain investigator site or the need to use research-naive sites. However, if previously used sites will be considered for a new study, it is vital to review some key information for a truly strategic site selection process. Let's take a look at some of these key, yet often forgotten, areas.
During the American College of Cardiology annual meeting in March, researchers from Stanford University, Apple Inc., and other academic centers unveiled the Apple Heart Study, a first-of-its-kind large-scale study involving more than 400,000 members of the general population (iPhone and Apple Watch owners). The goal of the study was to identify users with a potentially lethal irregular heart rhythm called atrial fibrillation (AF).
Patient behaviors have changed drastically in recent years. With the widespread adoption of digital technologies, such as wearable devices that transmit patient data, and a surge in health-related information available online, patients have become more knowledgeable and engaged in the management of their own health than ever before.
Our body’s immune system appears to be the most effective therapy to fight cancer—more so than chemotherapy, radiotherapy, or any other anti-cancer therapy currently available. However, the immune system is only effective if it can detect cancer cells.
We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?
As part of our ongoing series about best-in-class approaches for rapidly assessing, prototyping, and introducing digital and other clinical trial technologies, we focus our attention in this article on the “human” component of technology-enabled transformation.
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