Implementing a new technology presents many challenges for companies. There is the implementation itself, the training of users, managing the change, and finally providing support to users. A panel discussion at the 2019 Oracle Health Sciences Connect conference tackled these challenges, providing advice on how to manage all facets of a new technology implementation.
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.
Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.
While the revisions to the guideline mainly impact sponsors, technology providers and contract research organizations need to be aware of the changes and make adjustments to operational procedures, documentation practices, quality approaches and computerized system functionality.
How automating site grant payments can optimize payment processes for sites leading to greater site satisfaction and allowing sites to operate at peak performance and reduce errors.
Successful regulatory approval requires a deep understanding of the regulations, process and technical standards, as well as an appropriate regulatory strategy.
The way an individual interprets language is influenced by many factors, including culture, background, education, training, and personal biases. This article will look at the approaches Drug Safety and Pharmacovigilance teams can take to resolve these issues, allowing the pharmaceutical industry to receive the benefits of operating in a multicultural environment.
Genetic testing is making it easier to identify patients for clinical trials. However, genetic testing in the context of clinical trials raises raise important ethical issues, including ones related to informed consent and disclosure of results. Genetic counselors can play a crucial role in helping sponsors address these operational and ethical issues, making trials more efficient, more patient-centered and, ultimately, more successful.
This article provides practical solutions for overcoming the biggest challenges independent clinical research sites face in data collection. Further, it highlights three key metrics that will help sites improve performance and drive success.
A client was developing a new drug for complex neurodegenerative disease in pre-clinical development. The drug may be only effective for a particular subgroup of patients. They needed to generate a hypothesis on the molecular pathway and the targeted drug activity and identify a biomarker signature defining potential response to the new drug. Read how Cytel’s analysis produced a biomarker signature that was provided to the client for in-vivo validation.
Although there are clear benefits with the first pill to include a digital sensor that tracks if and when it has been ingested brings, there are also questions regarding patient privacy and choice.
CROs & Sponsors: Have we overcome the limitations of early site payment solutions? Learn how a Site Payment Advisory Group helped improve site payment technology for all stakeholders.
eCOA solution provides a truly patient-centric experience for optimal protocol compliance oncology patients an easy solution to use.
Learn how to find and hire competent CRAs in this free collection of articles highlighting CRA turnover as well as how to spot fraudulent resumes and counterfeit degrees.
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.
The appallingly low rates of patient participation in cancer clinical trials, especially in the community setting, is no secret. The fact is that 98 percent% of our patient population isn’t aware of available trials, doesn’t know how to apply, or is under too much financial and emotional strain, etc. to even consider joining a trial. The blame for this rightfully falls on the proverbial shoulders of the main stakeholders: the biopharmaceutical industry, healthcare institutions, government, and — yes — patient support groups.
Part 1 of this two-part article examined the implications the transition to value-based, patient-centric, precision medicine has for drug discovery, development, and deployment, particularly for clinical trials. Part 2 explores precision medicine in more depth regarding the tailored and targeted treatments that aim to match patients to medicines according to particular clinical, demographic, and lifestyle factors.
