In this ISSUE

Functional Service Partnerships: A Case Study for CRO Resource Management

CTMS: What You Should Know

ICH GCP Goes Risk Based

Regulatory Authorities, FDA

FDA and Industry Move on mHealth Guidance

Austin Speier, VP of Emerging Technologies at Precision for Medicine, recently spoke about mHealth regulatory pathways at PanAgora's Mobile Innovations Summit, and will elaborate further in this Q&A interview.
... /Read more/

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

Calendar

/ 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 /

/ Interactive Response Technologies in Clinical Trials 2017 10/26-10/27 /

Tomorrow's Clinical Trial, Powered by Modern EDC
See how to cut study build time in half, eliminate migrations, and remove the need for source data verification (SDV).

See a preview and watch the full webinar here.

Regulatory Authorities, EMA

EMA Rejects Milan Link in Top-level Talks with European Parliament

This article outlines the EMA's response from a previous blog by Peter O'Donnell regarding the potential of Milan, Italy as the EMA relocation.
... /Read more/

Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?
On Demand

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Risk Based Monitoring

Adoption of RBQM in Academic Settings: Lessons Learned

This article discusses the adoption of RBQM in academic settings and the lessons that were learned.
... /Read more/

Rare Diseases and the Eye - Envisioning Strategies for Success
Live Webcast: Friday, October 27 at 11:00am EDT

Ask the editor

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

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Mike Tessalone
Publisher
Michael.Tessalone@ubm.com

Clinical Trial News

Regulatory Changes Position China as a Global Clinical Trial Destination

George Clinical's Managing Director discusses the concern biopharma companies have with CFDA's slow drug and medical device approvals.
... /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

eClinical

Pharma Roundtable: Breaking Barriers to Using Mobile Technology on Clinical Trials

Jeff Lee had the opportunity to be a moderator at the Mobile in Clinical Trials event where he sat down with mobile experts within the pharmaceutical industry. The session allowed for new observations in regards to the value that these mobile technologies have within clinical trials.
... /Read more/

Accelerate NASH Development: Next-generation Approaches to Overcome Recruitment and Study Execution Challenges
On Demand

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