Technology has transformed our daily lives and now stands ready to disrupt and transform the way pharma companies conduct clinical trials. A study by ISR Reports attempts to determine the current status of mHealth in trials as well as make projections for its continued adoption in the future.
More than two years have passed since the 21st Century Cures Act was signed into law in December 2016. According to the FDA, the Cures Act is designed to help accelerate medical product development and bring new innovation and advances to patients who need them faster and more efficiently.
It is certainly no surprise that risk management continues to hold the spotlight as a hot topic within the biotechnology/pharmaceutical industry. With the increased focus by regulatory authorities on an organization’s ability to identify, mitigate, and control risks, the industry remains in a state of growth, developing and evolving practices to ensure proper alignment with industry best practices and regulators’ expectations. Many organizations are finding it difficult to establish and embed risk management practices, as doing so requires a paradigm shift from a traditional risk-averse industry culture.
Looking forward, it will be increasingly important for pharma companies to employ ingenious strategies to access data already existing in the healthcare environment, moving away from solely building and owning data sets. These new approaches will bring significant new opportunities and help companies to further differentiate their medicines from competitors and accelerate their products to market.
Dr. El Mustapha Bahassi, Associate Director of Clinical Laboratories at Medpace gives an overview of Central laboratories and the evolving world of immuno-oncology as well as current immuno-oncology biomarkers and detection methods.
Advancements in science and technology have helped researchers develop new treatments for some of the most common diseases known to man. For rare diseases, however, patients have limited treatment options. Advocacy groups and regulatory authorities continue to encourage rare disease research, and more and more scientists are stepping up to the task.
Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.This paper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.
This paper is intended as a discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.
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More than two years have passed since the 21st Century Cures Act was signed into law in December 2016. According to the FDA, the Cures Act is designed to help accelerate medical product development and bring new innovation and advances to patients who need them faster and more efficiently.
At Janssen, patients are at the center of everything we do. And we’re constantly working to improve their experience.
Good recruitment and retention is critical to the success of clinical trials. Get it right, and a trial will likely achieve its primary objective; get it wrong, and the time, effort, expense, and any patient participation is likely wasted. This article discusses how a new national approach to involving patients and the public in the U.K. is helping life sciences companies get it right the first time.
Degraded samples are common and certainly problematic for investigators. Read more about common causes of degradation as well as agents and systems available to protect against freeze–thaw.
Mike Novotny, founder and CEO of Medrio, shares an experience from early in his career of building databases that showed him by having the right data at the right time, doctors can make decisions allowing patients to live their best lives possible.
Conducting the advanced therapy supply chain orchestra is more than waving a stick at people – it is an “end to end”, complicated, inter-related system that requires controlled, consistent management. Following are some things you need to think about to develop the capability to provide a harmonious supply chain management system.
What it is, why it is important, and what sponsors need to think about as it gets closer.
Preventing patients from receiving “counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the US Food and Drug Administration (FDA). Chain of custody for genetic and cell therapies differs and is more complex than for traditional pharmaceuticals, and the requirements for documentation vary as well.
