In his role as product line owner for digital health at Janssen, Mark Sapp leads a team that works directly with different therapeutic areas inside the company. “Our focus is helping our clinical teams get from point A to point B,” says Sapp. “We assist them with taking their idea and scaling it up, identifying the clinical endpoints they hope to achieve, and helping them stay focused on the results they need to generate.”
Patient-facing digital technologies — also referred to as patient technology (PT) — have the potential to make a significant impact on the clinical research environment. PT includes any digital technology patients interact with to participate in clinical trial activities. When implemented effectively, these technologies can enhance patients’ experiences and engagement, streamline clinical trial processes, and enable better, more robust data collection in clinical trials.
Electronic consent to clinical research — “eConsent” — is a hot topic within the clinical research world as more sponsors and sites explore what solutions are available and appropriate for them. Yet many clinical trials are stuck in paper-based consent, either underutilizing the technology tools at their disposal or not using them at all. Understanding the reasons for a transition to eConsent and the hesitancies to make these changes gives insight into one of the last bastions of the clinical research industry to embrace the digital revolution.
As part of our ongoing series detailing an approach for the rapid assessment and prototyping of digital and other clinical trial technologies, we introduce here the use of artificial intelligence (AI) and machine learning (ML) to optimize clinical study design and execution.
This white paper addresses the growing interest in quality in clinical trial execution and how workflows play an essential role by building in the steps needed to comply with TMF guidelines, reducing downstream problems. This proactive strategy limits issues caused by siloes, yielding process improvements measurable by performance metrics.
This white paper focuses on defining and expanding the definition of study startup, an element of clinical trials that is gaining attention because it offers the greatest opportunity to improve quality while compressing clinical trial timelines.
The cloud has made anywhere/anytime, centralized monitoring (adaptive-on-site and off-site) of all risk-related trial factors a seamless reality. Looking ahead, the cloud can integrate centralized monitoring, risk management measures, and predictive analytics. It can also create risk repositories, to keep trial costs in check and optimize better quality results for life saving therapies.
As pharmacovigilance adopts next-generation technology by leveraging artificial intelligence (AI) and the cloud, new possibilities are opening up for knowledge generation – and thus value – from the data collected and processed. This paper looks at three important developments around drug safety data and their analysis and how industry is prepared for them.
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Patient-facing digital technologies — also referred to as patient technology (PT) — have the potential to make a significant impact on the clinical research environment. PT includes any digital technology patients interact with to participate in clinical trial activities. When implemented effectively, these technologies can enhance patients’ experiences and engagement, streamline clinical trial processes, and enable better, more robust data collection in clinical trials.
Electronic consent to clinical research — “eConsent” — is a hot topic within the clinical research world as more sponsors and sites explore what solutions are available and appropriate for them. Yet many clinical trials are stuck in paper-based consent, either underutilizing the technology tools at their disposal or not using them at all. Understanding the reasons for a transition to eConsent and the hesitancies to make these changes gives insight into one of the last bastions of the clinical research industry to embrace the digital revolution.
When you’re diagnosed with cancer, diabetes, an autoimmune disorder, chronic pain, a neurological condition such as Alzheimer’s disease, or another illness, having the safest, most effective medicine is paramount. Knowing a promising therapy is “in the pipeline” doesn’t bring you a whole lot of comfort. You want access to the most advanced medicines now.
HIV has been one of the largest public health challenges facing the world in the past few decades. Approximately 36.7 million people were infected with HIV, as reported by the World Health Organization, at the end of 2015. Despite the public attention and large population impacted by this virus, developing a cure for HIV has been particularly difficult. To successfully cure an infected individual the virus would need to be fully eradicated from their body, which is difficult because HIV is extraordinarily good at hiding in a person’s cells. In fact, part of the virus’ replication cycle is to insert itself into the host’s DNA. Once there, HIV appears to be undetectable and it can stay in the cells for the lifetime of the cell. In this state, the virus is termed “latent.”
CRAs are tasked with making sure all documentation and data is as it should be: current, compliant, and following the study protocol(s). Read how with cloud-based web and mobile eTMF solutions, CRAs can throw away their spreadsheets and experience the following process improvements.
Maintaining the appropriate storage temperature of biological material is critical for downstream use. However, due to the complexity of this material and its sensitivity to temperature we are seeing an increase in non-traditional storage temperature requests. In this article, we’ll explore some of the reasons why this is occurring and the associated challenges.
Patient-facing digital technologies — also referred to as patient technology (PT) — have the potential to make a significant impact on the clinical research environment. PT includes any digital technology patients interact with to participate in clinical trial activities. When implemented effectively, these technologies can enhance patients’ experiences and engagement, streamline clinical trial processes, and enable better, more robust data collection in clinical trials.
The most common storage is ultra-low temperature storage, but the fastest-growing is cryogenic, in vapor phase liquid nitrogen. This transition is huge. Chain of temperature data and chain of custody in handling is imperative to the pharmaceutical industry of today. These additional factors partly explain the much higher cost of these therapies as well. The three primary issues are: capacity, regulatory, and risk. We’ll look briefly at all three.
