ACT

NOV.8/2016

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news roundup

Nobelpharma Selects Medidata Clinical Cloud

Medidata's Clinical Cloud solution has been adopted by Japan's Nobelpharma to power a clinical trial on sleep disorders in children with neurodevelopmental disabilities.


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New Research Shows Pharma's Rapid Adoption of Digital Health in Trials
Download this complimentary research report analyzing survey responses from nearly 200 global pharma companies, CROs and tech providers to learn how many pharma companies are using digital health, endpoints pharma is most interested in tracking with digital health technologies, key business drivers fueling the adoption and utilization of digital health and more.
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Schulman IRB Launches Oncology Division

Schulman IRB will launch its new Central Oncology Review (COR) division this month. The COR will feature a roster of oncology industry leaders, academics and scientists, each with a background in managing specialized oncology research.


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CBI's Clinical Data Disclosure and Transparency is the most comprehensive meeting of its kind! Join your peers on January 18-19 to disseminate aspects of required data disclosure in a time of industry reform. Spend your time with a laser focus on the implications of and approaches being taken for data sharing, ensuring compliance with regulations, navigating disclosure requirements and releasing patient-level data.
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European Patient Initiative Hits Five Years

The European Patients' Academy (EUPATI) is a pan-European Innovative Medicines Initiative project of 33 organizations, led by the European Patients' Forum, with partners from patient organizations (the European Genetic Alliance, the European AIDS Treatment Group, and EURORDIS), universities and not-for-profit organizations, along with a number of pharmaceutical companies.


ICON Connects to EMR's Through TriNetX

TriNetX is a research network and technology platform that connects ICON to the EMR systems in its expanding network of healthcare organizations to conduct real-time feasibility reviews and assess inclusion and exclusion criteria that have the most impact on patient recruitment.

In this edition

European Patient Initiative Hits Five Years
ICON Connects to EMR's Through TriNetX
Clinical Data Transparency: EU Prospective
mHealth— Remote Monitoring of Patients in Clinical Trials

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Drive better outcomes with improved trial design
Live Webinar: Tuesday, December 6 at 11am EST
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The Next Wave of Centralized Monitoring
Live Webinar: Thursday, November 10 at 11:00 AM EST
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Events

CBI's 2nd Annual Clinical R&D Financial Tracking & Analysis Summit
eCOA/ePRO Summit
Clinical Trial Data and Transparency
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Vendor Overload? Integrating third party lab management to streamline clinical development
On Demand
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Articles

Clinical Data Transparency: EU Prospective

This article outlines the journey the EU has taken to improve access to clinical trial data through its regulations for posting in a web portal, layperson summaries and more.

 

Rare Disease Research: It Pays to Engage

Juliet Moritz, executive director of strategic development in rare diseases for CRO Premier Research, discusses the challenges and opportunities related to rare diseases, particularly as it relates to patient engagement.

 

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Click here and press play in our video player to watch a short video about Covance's Xcellerate Monitoring solution, to help you prioritize patient safety and data quality, support protocol compliance, and optimize resource utilization.

 

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Continuous Glucose Monitoring (CGM) in Clinical Trials: An Evolving Regulatory Landscape
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mHealth

mHealth Wearables Survey Report

Applied Clinical Trials and SCORR Marketing conducted a survey to delve deeper into mHealth technology, this time with special emphasis on wearable technology. Download the free report for information on companies' current use of mHealth wearable technology in clinical trials; attitudes toward present and future; concerns over data security, costs, and more.


Emerging Markets Could Benefit from mHealth

Environments free of legacy systems have the advantage of building comprehensive, “right-by-design” digital and mHealth models spanning all trial operations.


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The Evolution of Regulatory Affairs
Live Webinar: Wednesday, December 7 at 11:00am EST
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Remote Monitoring of Patients in Clinical Trials

By contributing to a more patient-focused, primary setting healthcare model, mHealth can support a shift towards prevention and at the same time improve the efficiency of the system generally.


Blog Posts

FDA, Industry: A Disconnect on Patient Centricity?

The concept of Patient Centricity continues to evolve, as the biopharmaceutical industry and regulatory agencies' perspectives on the topic seemed to gel, but, there are slight differences in interpretation.


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Regulatory Changes in India and What It Means for Clinical Research in the Country
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Getting the “Right” Patient Input into Decision-Making

Customers' views and demands may not always share the logic of the systems that generate their products.


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Simplifying the complexities of global rare disease drug development
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Ask the editor

Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com

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Mike Tessalone
Publisher
Michael.Tessalone@ubm.com