In this ISSUE

The PUEKS Project: Process Innovation in Clinical Trial Monitoring

Interventional vs. Non-interventional Study Classification in the EU: Considerations on the Impact of Direct-to-Patient Contacts

Measuring Adoption and Value of Patient Engagement

Regulatory Authorities, EMA

Senior Italians Confer in EU on EMA Relocation

What cannot have escaped the attention of any impartial observer is that Milan is one of the leading contenders to host the EMA and that Tajani and Rasi are both Italian. The EMA relocation is a hot topic without any bias towards Milan.
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15^th Annual Global Forum
Sept 25-29, 2017
Hyatt Regency McCormick Place, Chicago, IL

Returning for its 15^th 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.

Calendar

/ Global Risk-Based Monitoring 9/14-9/15 /

/ Real-World Evidence Forum 9/27-9/28 /

/ Rare Diseases & Orphan Products Breakthrough Summit 10/16-10/17 /

/ Speed to IND for Biologics 10/19-10/20 /

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

Therapeutic Specific Areas

Exploring Strategies for Testing Medical Products on Pregnant and Lactating Women

The National Institutes of Health (NIH) focuses on developing strategies that will encourage further research to support safe and effective therapies for pregnant and lactating women.
... /Read more/

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

Clinical Operations

The Clinical Trial of Tomorrow

Highlighting the six broad technology themes poised to transform future R&D.
... /Read more/

Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?
Live Webcast: Tuesday, September 26, 2017 at 1:00pm

Ask the editor

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

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Mike Tessalone
Publisher
Michael.Tessalone@ubm.com

Trial Management

Components of an mHealth Consent Form

As the clinical trials industry starts to incorporate mHealth initiatives into their trials, study teams now have to determine the extent of their ICF consent forms during study deployment, and how to cover mHealth activities within these forms.
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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

Regulatory

ICH E6 R2 Roundtable Review

The release of the ICH E6 R2 guidance, which outlines a new approach to clinical trials operations, will have a major impact on the industry, writes Patrick Hughes.
... /Read more/

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