Applied Clinical Trials Trends

In this ISSUE

EMA Gives Open Access to Clinical Data on New Medicines

Antidote Incorporates Patient Centricity in Subject Enrollment

CRO/Sponsor Relationships

The Changing Role of the CRO and its Effect on Project Management

Market trends are driving the need for biopharma to decrease fixed costs, leading to increased outsourcing to CROs.
... /Read more/

Click here and press play in our video player to watch a short video about Covance's Xcellerate Monitoring solution, to help you prioritize patient safety and data quality, support protocol compliance, and optimize resource utilization.

Regulatory Affairs

FDA & Industry Share Perspectives on Patient Centricity

As patient centricity continues to evolve, the differences in perspective between sponsors and the FDA over how to define this concept run parallel.
... /Read more/

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.

Click here to listen

Industry Trends

Centralizing Your Clinical Trials Office

Hospitals and health systems are making significant changes to their research operations in conjunction with the increasing complexities of clinical research.
... /Read more/

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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Drive better outcomes with improved trial design
Live Webinar: Tuesday, December 6 at 11:00 am EST

Calendar

/ Clinical R&D Financial Tracking & Analysis Summit 11/17-11/18 /

Philadelphia, Pennsylvania

/ Cannabis-Based Therapies 11/30-12/1 /

Berlin, Germany

/ Clinical Trial Agreements, Investigator Payments and FMV 12/6-12/7 /

Philadelphia, Pennsylvania

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

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

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Patient Centricity

Getting the “Right” Patient Input to Decision-Making

Rising patient engagement in drug development has been welcomed when it comes to discussions of policy.
... /Read more/

The Evolution of Regulatory Affairs
Live Webinar: Wednesday, December 7 at 11:00 am EST

Executive Profile

Rare Disease Research: It Pays to Engage

With pursuits in rare and orphan disease beginning to move more into the drug development mainstream, the opportunities and challenges in patient engagement and trial execution for these conditions are ever-evolving.
... /Read more/

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Ask the editor

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

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