Disruptive innovation is a hot topic in clinical trials. So is patient centricity. While some innovations will help sponsors more effectively manage the drug development process, some are also poised to have a significant impact on patients taking part in studies. In this Q&A article, Melva Covington of Sanofi and Ross Weaver of Clinical SCORE discuss innovation, FDA mandates, and industry efforts to get patients more involved in clinical trials.
Clinical trial nurses help increase patient enrollment and retention rates by bringing the clinical trial to the patient. Studies utilizing clinical trial nurses are more accessible, more convenient, and therefore much more patient centric.
This paper examines the opportunities and challenges of conducting clinical trials in China, and offers proven strategies for overcoming hurdles.
Randomized, double-blind clinical trials are the gold standard for adequate and well-controlled studies in modern times. However, prior to the late 1940s, randomization and blinding were not used in medicine and as result, bias was common.
According to The STM Report (2015), more than 2.5 million peer-reviewed articles are published in scholarly journals each year. PubMed alone contains more than 25 million citations for biomedical journal articles from MEDLINE. The amount and availability of content for clinical researchers has never been greater – but finding the right articles to use is becoming more difficult.
Read our whitepaper on comparator drug, the mistakes companies make and tips for getting the best deal on sourcing.
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.
Medidata RBM is Medidata’s risk-based monitoring application (RBM) that allows you to design and conduct any RBM program.
World Courier pioneered the development of an advanced technology to streamline the management of clinical trial logistics. Unparalleled within the industry, World Courier’s cutting edge technological innovations provide you with logistical tools to effectively manage your study – from the pre-trial phase right through to your last shipment.
Because cardiovascular diseases claim millions of lives around the world each year, new and innovative therapies are in high demand. inVentiv Health Clinical’s dedicated cardiovascular team offers expertise in all stages of clinical program design, development, and efficient execution.
Full capability is the approach inVentiv Health takes to bioanalytical development regardless of your project size. Through our GLP-compliant laboratories, an extensive list of validated assays, custom assay services, knowledgeable scientists, and skilled technicians, inVentiv Health Clinical provides bioanalytical services in all stages of drug development.
TrialMax Web™ is a web-based diary specifically designed for late phase trials, which tend to be larger and longer in duration.
World Courier is the largest, most successful specialty courier company in the world. Each dot represents one of over 140 company owned offices, nearly ten times the number of offices of all other specialty courier services combined!
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.
Visitors are enriched with valuable information on CRO, Pre-Clinical Contract Research Organization, Bio-Analytical Contract Research Organization, Clinical Contract Research Organization, Pharmacovigilance, Clinical Data Management, Electronic Patient Reported Outcomes (ePRO), Point-of-Care Testing (POCT), Patient Recruitment, Electronic Data Capture (EDC), Clinical Trials Management Systems (CTMS) and more that can improve your business and make it more profitable.
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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.
The evaluation of the compatibility between scores from an electronic version of a paper-based questionnaire, better known as equivalence testing, is usually taken as a requirement for ensuring that data from electronic versions of patient reported outcomes does not vary from that captured on paper. This webinar discusses the results of a recently published meta-analysis which examined all published equivalence tests from 2007 to 2013. This webinar discusses equivalence testing, how the current meta-analysis run, and what the results mean in context of the field of eCOA.
Interest in using electronic patient reported outcomes (ePRO) on smart devices is on the rise. In this webinar, Emily Cantrell and Becky Baggett will share lessons learned working on a large phase 3 pain study that utilizes ePRO on tablet devices.