In this ISSUE

Is Europe Creating a Coalition to Combat Big Pharma?

Oncology Therapy-Focused RACT Emerges

How Does GDPR Affect Clinical Trials?

Debunking the Myths of Risk-Based Monitoring for a New Approach to Quality Management
On Demand

The EMA

Are Clinical Trial Data Shared by the EMA Under Policy 0070 Really Public Data?

The general assumption that the Policy 0070 data releases were public data releases can be challenged since there is a mechanism to enforce the ToU, and this mechanism will continue to exist after the Agency moves to the Netherlands.
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Predicting Holistic Clinical Trial Cost Should Not Be A Struggle
Ying Jiang Explains What You Need To Know
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Therapeutic Areas

Any Cancer Can Be a 'Rare Cancer'

With more common cancers now increasingly broken down by specific genomic defects, the future of research for any cancer is entirely, and unequivocally, molecular.
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FILLING THE GAPS IN SITE SELECTION
What You Don't Know Can Help You
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Calendar

/ Direct-to-Patient Clinical Trials /

/ American Pharma Outsourcing Summit 10/2-10/3 /

/ Crossroads: An Artia Solutions Conference 11/7-11/9 /

Driving Product Development and Finding the Fast Track in Early-Phase Oncology Programs
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Ask the editor

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

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Todd Baker
Group Publisher
todd.baker@ubm.com

Is RBM living up to the hype? The state of RBM in clinical development
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Health Policy

Does the EU Really Care About Health Policy?

How much does the EU really care about health, and about the infrastructure that is a precondition to successful healthcare and healthcare innovation?
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The Future of ECOA
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Medical Monitoring

Medical Monitoring Risk Exposure in New Regulatory Climate

In this article, we will discuss trends and challenges with medical monitoring clinical analytics, analyze the alignment of existing medical monitoring tools and technologies with ICH-E6 (R2) addendum guidelines, and discuss trends in medical monitoring insourcing and outsourcing models.
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Patient Centricity

Five Steps to Making Your Clinical Trials Patient-Centric

Companies can utilize the following five tools to set themselves up for a successful trial.
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