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.
Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.
How IRT vendor relationships can ensure high quality builds that meet pharma companies' needs and avoid the potential pitfalls associated with RTSM.
In this digital age, virtual trials may very well become the norm at some point in the future, but there are many questions to answer before this can become a reality. In this white paper, we propose how virtual trials may be able to solve all these issues at once while also providing the added benefit of reducing costs related to study sites.
How are consumers engaging with their healthcare in today’s environment and what drives engagement, and what hinders motivation or ability to engage? This study explores these questions.
The big challenge for study sponsors is that clinical trial transparency remains a “volatile” area with continuously evolving requirements and expectations. Most life sciences companies don’t have the time, money or resources to develop a compliance solution.
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.
Five characteristics to look for when finding the best-fit site for your study.
Accurate and timely delivery of clinical trial supplies helps to ensure that a study’s timeline stays on track. Sponsors often focus on upfront planning to ensure sites are prepared to reach clinical milestones but ignore the logistical challenges of reconciling and destroying clinical returns. This article breaks down how to effectively manage the clinical supply returns process and how to design a more holistic strategy.
A breakdown of regulatory guidances and a clear picture of what the IRB needs to see.
Discover how Almac helped one pharmaceutical company streamline processes and remove risk from their multiple clinical trial applications while maintaining data integrity with One Unified Clinical Trial Supply Solution.
What can you do during your study to maximize your chances of success when it comes time to submit?
Best practices to ensure a successful sponsor-CRO collaboration
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.
