Applied Clinical Trials Trends

In this ISSUE

FDA Highlights "Flexibility" in Approving Rare Disease Therapies

My 3 Key Reflections on Partnerships in Clinical Trials USA 2016

The Drive for Technical Innovation – Addressing Clinical Study Challenges

Opinion

Risk-Based Monitoring: What Does it Mean for Clinical Study Sites?

Risk-based monitoring continues to remain in the spotlight as an accepted and oft implemented approach that is likely to become an industry standard.
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Click here and press play in our video player to watch a short video about Covance's Xcellerate Insights collaborative workspace, making sharing and information access among project teams easier, more secure, and more efficient.

Clinical Operations

Digital Innovation in Enhancing Clinical Trials

Digital innovations are enhancing clinical trials in several ways including recruiting, patient engagement and streamlining data management.
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Podcast: E-Signatures and Digital Workflows in Clinical Trials
In clinical trials, the use of eSignatures to improve document workflows such as protocols, informed consent, and investigator brochures, has increased. All documents that need signed approvals eSignatures can be implemented to streamline, improve and make the transferring of those documents more efficient. This podcast discusses areas in clinical trials where eSignatures and document workflow can be applied for upstream benefits.

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Regulatory Affairs

CDISC Standards Key to Meeting FDA Regulations, Research Goals

The deadline looms for new FDA requirements that all applications for new drugs and biologics compile and submit clinical trial data electronically.
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Read this interview with IBM company (eClinical Division), discusses risk-based monitoring (RBM) and how the company is innovating a 25-year-old manual process to enable better monitoring decisions.

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The Next Wave of Centralized Monitoring
Live Webinar: Thursday, November 10 at 11:00 AM EST

Calendar

/ IRT 2016 10/25-10/26 /

Philadelphia, Pennsylvania

/ Exploratory Clinical Development 10/26-10/27 /

Berlin, Germany

/ RBM 2016 11/3-11/4 /

Philadelphia, Pennsylvania

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

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Regulatory Affairs

Trying to Get Inside EMA's New Clinical Trial Databank

The European Medicines Agency has started to deliver on its promise of open access to clinical reports for new medicines authorized in the European Union.
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The Evolution of Regulatory Affairs
Live Webinar: Wednesday, December 7 at 11:00am EST

Opinion

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

A new clinical trial regulation in Europe aims to bring about harmonization of European Union (EU) clinical trial multi-country applications.
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Ask the editor

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

Regulatory Changes in India and What It Means for Clinical Research in the Country
On Demand

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Mike Tessalone
Publisher
Michael.Tessalone@ubm.com

Simplifying the complexities of global rare disease drug development
On Demand

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Drive better outcomes with improved trial design
Live Webinar: Tuesday, December 6 at 11am EST

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