In this ISSUE

Non-Adherence: A Direct Influence on Clinical Trial Duration and Cost

The Future of Clinical Trial Modernization: What's to Come in 2018

Medical Monitoring Risk Exposure in New Regulatory Climate

EMA

Brexit Goes from Bad to Worse for Medicines

With looming workforce loss—now much higher than first anticipated—prompting further cutback plans at EMA, the threat to drug developers, suppliers, and patients is intensifying.
... /Read more/

Challenging the Status Quo: The Diffusion of Technology in Study Startup
Tuesday, September 25, 2018 at 1pm EDT | 12pm CDT | 10am PDT

Investigative Sites

How to Detect, Manage, and Report Fraud and Fabricated Clinical Research Data

This article examines the ways to detect fraud and data fabrication within a clinical trial.
... /Read more/

A Next Generation Sequencing Approach to Influenza Vaccine Development
Thursday, September 20, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Audits

Can Sponsors Answer 6 Questions Regulators Ask During Audits?

Switching from paper records to an electronic drug accountability IRT system can benefit sites during FDA trial site audits.
... /Read more/

Decoding the Distinction: DMCs, CECs, and Their Role in Medical Device Research
Wednesday, September 12, 2018 at 11am EDT | 10am CDT | 4pm BST | 5pm CEST

Therapeutic Areas

A Glimmer Is All That's Needed for Alzheimer's

Although Biogen's Alzheimer's drug candidate BAN2401 addresses buildup of amyloid plaques, investors and scientists look to reevaluate the plaque theory and search for a glimmer of hope in breakthrough treatments.
... /Read more/

The FDA

Scientific Advances Require Innovative Clinical Research Models

FDA is testing various strategies to streamline research and regulatory oversight by looking to novel clinical trial designs to advance new treatments.
... /Read more/

Calendar

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

/ Basket and Umbrella Trials for Oncology 10/17-10/18 /

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

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Lisa Henderson
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Lisa.Henderson@ubm.com

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Todd Baker
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todd.baker@ubm.com

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