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news roundup
The Reagan-Udall Foundation launched the Expanded Access Navigator for physicians, patients, and caregivers to provide guidance on EA, also known as compassionate use, named-patient use, or single-patient access.
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ERT Video Series
Check out the ERT video series, filmed on the show floor at DIA 2017, for interviews on Innovating Clinical Trial Management, eCOA in Clinical Research: Trends and Advances, and Optimizing Clinical Trial Imaging through Advanced Technology.
 Click here to watch all 10 short videos |
CTTI experts have created a set of recommendations and tools designed to help diverse stakeholders identify and develop novel endpoints based on data from mobile technologies for use in regulatory clinical trials.
In July, the National Academies of Sciences, Engineering and Medicine (NASEM) issued its “public health” framework for how FDA should review new pain treatments. Many of the NASEM recommendations resemble initiatives announced by FDA commissioner Scott Gottlieb to update FDA's response to the opioid crisis.
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About Bridging Clinical Research and Clinical Health Care Collaborative
The Bridging Clinical Research and Clinical Health Care Collaborative is sponsored by SCORR Events, a division of SCORR Marketing, the leading marketing and communications firm in the health science industry. SCORR Events was established to provide education, collaboration and opportunities for industry professionals to advance health sciences.  Learn more
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The revision takes into account the fact that in the past 10 years trial protocols have become increasingly complex and now often include different parts within a single clinical trial protocol, aimed at assessing for example single and multiple ascending doses, food interactions, or different age groups, according to the agency.
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15th Annual Global Forum
Sept 25-29, 2017
Hyatt Regency McCormick Place, Chicago, IL
Returning for its 15th iteration, the world's largest event for temperature-controlled life science supply chains heads back to Chicago this year with a focus on the next generation of temperature control! Join 850+ attendees from 30+ countries for five days of master classes, workshops, track sessions, panel discussions, roundtables, and more. With the Global Forum, your company will meet emerging and ongoing challenges for 2017 and beyond.
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Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?
Live Webcast: Tuesday, September 26, 2017 at 1:00pm EDT
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Articles
In our latest survey with our partner SCORR Marketing, Applied Clinical Trials asked its audience about the status of global trials. Overall, many themes that have always concerned industry with multi-regional clinical trials still ring true.
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Clinical Trial Simulation: An Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions
Live Webcast: Tuesday, September 19 at 2:00pm BST and Thursday, September 28 at 10am EDT
 Register now |
This peer review article examines enrollment efficiencies in a global chronic kidney disease trial where a large pharmaceutical sponsor used point-of-care diagnostic testing (POCT) at investigator sites to pre-screen prospective subjects prior to sending samples for central lab (CL) screening in order to reduce CL screen failures.
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Blog Posts
Executive Director of the European Medicines Agency, Professor Guido Rasi, and European Parliament President, Antonio Tajani met in late August, spurring speculation that Milan is at the top of the list for the new EMA headquarters.
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Accelerate NASH Development: Next-generation Approaches to Overcome Recruitment and Study Execution Challenges
Live Webcast: Monday, September 18 at 11:00am EDT
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The NIH has launched a process for identifying policies and strategies likely to encourage more research on safe and effective therapies for pregnant and lactating women, including the ethical issues related to enrolling such patients in clinical trials.
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