Clinical news roundup for the week of May 22, 2016 with articles on EU legislation, five major trials set to announce results, BIO releases study on clinical success, trials in Australia, fear as a roadblock to oncology recruitment, and more.
A quick glance at the pharmaceutical industry news may indicate the golden age of biosimilars is just around the corner. Approved biosimilars could account for more than $20 billion in revenue and save EU and U.S. health systems more than $56 billion by the end of 2020, two recent reports concluded.
It’s well known that clinical trials have become increasingly complex and costly over the past few decades.
Underperforming investigative sites have long been a puzzling issue for clinical trial stakeholders. There are lots of reasons for sub-optimal performance, ranging from inadequate processes for study execution to overly complex protocols.
Immunotherapies harness the power of the body’s own defense mechanism, the immune system, to combat disease. They were initially introduced in the form of non cell-based biologics and vaccines, such as the splurge of products known as the check-point inhibitors designed to target the PD1/PD-L1 immune pathway. An individual would be injected with a weakened form of a virus, exposing the body to the disease and prompting the immune system to produce antibodies to fight the infection from the live virus.
Managing clinical supplies effectively and efficiently requires a skillful blend of art and science to balance dozens of variables and considerations in order to create a fully optimized supply chain strategy.
Educating physicians is a prime goal in the U.S. in order to ensure biosimilars are prescribed. However, are the U.S.'s emerging biosimilar policies already at risk of alienating physicians?
The FDA has faced questions and criticism over its slow progress with biosimilar-related policies. In the face of these questions, however, the FDA has not provided any estimates or figures about the size of the biosimilars review team or the team's workload. Now, a new review released by ERG breaks down the agency's workload volume and costs, giving clearer insights into how the U.S. regulatory landscape is unfolding.
There are plenty of industry insights available, such as Life Science Leader’s comprehensive December 2015 Outlook issue for 2016 or our four-part trendsetter series. And while these provide a wealth of insight, I felt compelled to put together one last blog to prevent you from being blindsided by the “Next Big Thing” in biopharma in 2016.
As social media becomes a permanent fixture in patients’ lives and pharmaceutical companies’ business strategies, companies are turning to social media to advertise, inform, and recruit patients. However, there are still a number of mistakes pharmaceutical companies make when initiating social media recruitment efforts.
If the method used to determine whether or not a protein is a viable target for drug development were improved, pharmaceutical companies could potentially avoid the losses associated with finding out too late that a drug has harmful side effects and/or a lack efficacy. So how can pharma do this? Well, fortunately for them, some new technologies are now available to enhance their ability to select and evaluate safer targets in improved cell systems.
Our TrialStudio® tool enables us to design and adapt eCOA questionnaires quickly, saving you set-up time by leveraging re-use of instruments and diary components.
We believe that patient engagement is an essential component to every clinical study. We work with our clients to create a customized communication plan for each study which combines patient profiling (demographics, location and condition-specific drivers) with critical study parameters.
We identify the best data collection networks for each locale and patient population to ensure even your most complex clinical study is globally optimized and runs trouble free.
Medidata Balance® is the randomization and trial supply management (RTSM) application built within the Medidata platform to unify randomization, trial supply and EDC.
Our collaborative design process and TrialMax® technology allows us to work closely with study teams from the start. This allows us to develop the very best and easy-to-use eCOA design for your clinical trial rapidly and cost-effectively.
Clinical Reach is an enterprise strength cloud-based technology platform that enrolls, engages, connects, and reports on subjects anywhere in the world through a single interface.
From a single resource to completely managed teams, we offer short-term or long-term contracts for a contingent workforce with experience that crosses all phases, therapeutic areas, skill sets and geographies. Additionally, we work closely with hiring managers to ensure direct-hire or permanent placement candidates match your required experience and culture.
Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
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This webinar will address common collaboration obstacles from both the CRO perspective and the sponsor perspective with a focus on increasing the value of strategic partnerships.
The industry's shift from paper to electronic Clinical Outcome Assessments (eCOA) in clinical trials is happening at dizzying speeds.
Learn about mobile innovation for virtual, hybrid, and site-based clinical trials using the Clinical Reach™ mClinical™ platform for patient enrollment, engagement, and management on a global scale. Followed by an in-depth Q&A session and Parallel 6 Chief Medical Officer, Brad Pruitt, M.D., MBA, who demonstrates the newly released mobile data monitoring solution which is designed to empower clinical research associates (CRAs).
Learn how innovative mobile technology helps clinical trial participants stay engaged and compliant through the empowerment of the patient’s loved ones. Speaker, Stephen J. Freedland, M.D. (Urologist at Cedars Sinai DEPT of Surgery), presents a compelling case discussion on the importance of patient compliance and market approval, followed by Chief Medical Officer of Parallel 6, Brad Pruitt, M.D., MBA, who demonstrates the new Clinical Reach™ companion app followed by an in-depth Q&A session covering clinical use and various trial applications.