In January 2016, The New England Journal of Medicine published the results of a pivotal Phase 3 study of VIBERZI (eluxadoline), a treatment for adults suffering from irritable bowel syndrome (IBS) with diarrhea. The results were from two randomized, multicenter and multinational double-blind, placebo-controlled trials.
Clinical trials fit around the lives of patients, instead of vice versa, making participating in research less onerous. Yet, as an industry, we have failed to expand these benefits to other key stakeholders: sites, investigators, and study teams.
A few months ago, I contributed an article on making GMP training more practical. In this article, we’ll expand on the topic and look at making GMP training more engaging and meaningful — to benefit both the business and its personnel.
Everyone involved in clinical trial recruitment online is understandably obsessed with content. After all, a well-designed trial landing page is a powerful tool for attracting prospective enrollees. But this still leaves out a crucial part of the equation: how you can effectively target that ideal audience in the first place.
When a clinical trial does not unfold as planned, it may be heading for rescue. Communication problems among stakeholders, patient enrollment delays, overly complex protocols, and poor site compliance are just a few of the many reasons why rescue action is needed.
The internet and social media have transformed life, as we know it. Facebook, twitter, blogs, online videos, podcasts, tagging, wikis, search engines – all of these digital age tools have made people more interconnected and information more accessible than ever before. As a result, the concept of using the crowd as a resource for funds and ideas has made major inroads into modern society, being utilized in such diverse fields as journalism, law enforcement, product design, graphic design, architecture, and much more. Recently, some have begun to explore the utilization of the crowd for various purposes in medical research, including fundraising as well as crowdsourcing for intellectual analyses and insights.
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.
Patients have become more empowered, better informed, and more financially invested in their health and well-being than ever before. As a result, we have seen the healthcare landscape evolve toward a patient-centric delivery model.
Everyone has experienced poor customer service in one form or another. Say you want to call a company with a question or a complaint about a product. You’re likely to be informed by an automated voice that, “Due to the high volume of calls we are currently experiencing, your anticipated wait time will be X minutes. For faster and more convenient customer service, please visit our website at www.wedon’tcaretospeaktoyou.com.
Led by industry safety expert, Annette Stemhagen, DrPH, FISPE, UBC’s Risk Management, Registries & Epidemiology team brings unmatched passion and commitment to your product and your reputation.
In order to achieve effective endpoint case management, a structured and consistent process needs to be implemented.
Optimizer is BioClinica's powerful forecasting and demand planning technology used by the world's largest pharmaceutical companies to manage global logistics of the clinical supply chain. Managing supplies based on demand creates opportunities for savings and efficiencies in numerous areas, eliminating the high cost of waste as well as shortages that threaten timelines, budgets and even study integrity.
Whether you are a central IRB in North America or an IRB or Ethics Committee affiliated with a hospital, Trial Interactive has the ideal solution to streamline your processes.
The right eClinical partner can make your next clinical trial easier for you, your investigators, and even your subjects. The BioClinica suite of eClinical solutions is designed to do all this at a price that helps your bottom line as well. Our flexible and innovative eClinical solutions deliver ease of use without compromising power or features. There's no need for additional resources or IT investments and no learning curve or lengthy training period. We provide everything you need to run a successful eClinical trial, from forms and edit checks, to reporting and coding. Designed to work together or independently, scalable to the smallest or largest study, and able to maximize data visibility and utility via SharePoint and built-in connectivity to Outlook and other Microsoft Office applications, BioClinica’s eClinical solutions are the key to running faster, more efficient clinical trials.
BioClinica is the leader in medical imaging services, providing pharmaceutical, biotech, and medical device companies with comprehensive clinical trial support. Our experience spans all clinical trial phases for a wide range of therapeutic areas and indications. Our therapeutically aligned teams have experience with the latest advancements in medical imaging modalities, molecular imaging tracers and disease biomarkers, offering you an innovative solution for your clinical trial. BioClinica’s rigorous QC measures ensure your clinical trial data from every patient at every site is of the highest quality and is compliant with regulatory guidance.
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.
Please take a moment to join our community and discover the benefits of your free membership.
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.
Watch the webinar now to learn how an innovative approach can improve the clinical trial experience and move medicine forward.
Find a CRO with BIOCOM’s drug development guide which provides a description of each phase along with a list of companies that can accommodate your needs in the drug development cycle.Get more info...