One of the goals of CDER (The FDA’s Center for Drug Evaluation and Research) is to foster patient-focused drug development. As part of that effort, the agency has published a compendium of clinical outcome assessments (COAs) to promote the use of patient-focused outcome measurement in the drug development process.
The pharmaceutical industry lags in the sophistication and performance of its supply chains when they are compared with best-in-class companies in other industries. This is due to the complexity that has come with new drugs, more complex production technologies and evolving regulatory requirements. In this environment, integrating and aligning the supply chain makes it more flexible, bolstering operational performance and financial competitiveness.
In the foreseeable future, biopharmaceutical companies that do not allow those working on clinical trials to have mobile access to the systems and data they need, will be at a competitive disadvantage. Internal users, investigator sites, Clinical Research Organizations (CROs), central labs, and other vendors all have a growing expectation that they can access trial data and applications “where they live,” in other words, on their mobile devices.
Now more than ever, maintaining a competitive advantage includes a delicate balance of sharing information, collaborating effectively, and quickly resolving issues as they arise. A technology-based study startup solution is not only critical to staying ahead; managing its implementation is key to an easy and successful rollout process.
Understanding the technology landscape of SSU optimization and how different tools interact is key to accelerating study startup. Not only does each tool play a distinct role; ensuring they play well together is vital to ensuring faster start times, elimination of redundant work, and more efficient processes.
understanding the roles of eTMF, CTMS, and study startup solutions in the clinical trials process.
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.
LabConnect offers the scientific expertise for an extensive array of specialized testing options including oncology assays, biomarker analysis, pharmacokinetic analysis, and method development services. With more than 4,000 validated tests across its global network of central laboratories, LabConnect also provides the project management and client service tools needed for ensuring data and sample integrity.
Medidata CTMS™ is a centralized, enterprise clinical trial management system (CTMS) that helps effectively deploy critical resources, proactively address performance issues and streamline operational workflows. Powerful, configurable modules automate critical trial management and administration functions, including monitoring and payments.
Studies where patients use a medical device at home provide a great opportunity for leveraging the eCOA solution in automating data collection from the medical device.
inVentiv Health's Late Stage leaders help world class companies bridge the gap from development to commercialization.
We will collaborate with you to design a customized base IRT system that meets your unique requirements.
If you use goBalto Activate for study startup, you have a wealth of data for sites, study countries, and study document and submission activities that you can use in reports and analytics.
Medidata Payments is a cloud-based system to automate your site payment process.
All clinical trials collect regulatory documentation in order to receive authorization to conduct the trial at investigative sites. Trials require a Regulatory Binder and many keep separate Study Binders.
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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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.
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.
This webinar will discuss some of the benefits of an eSource approach, which include eliminating double entry of data and the need for source data verification, reducing the need for data queries, and optimizing monitoring time.