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In this ISSUE

Updated CDISC Glossary

Using Public and Private Data for ClinOps

The Role of Big Data in Clinical Trials

Industry Trends
Innovation: What's to Come in 2017
With much happening in the clinical trials industry during 2016, Moe Alsumidaie looks back at some of the innovations that took place and forward to what the industry can bring us in 2017.
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Are Local IRBs Really Necessary?
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Regulatory Affairs
FDA Binding Guidance: A Pivotal Milestone for CDISC Standards
For those still waiting, the time is now to get compliant on FDA's new data submission requirement.
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Trial Management
New Benchmarks for Trial Initiation Activities
Assessing practices and inefficiencies with site selection, study start-up, and site activation.
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Clinical Operations
Subject Profile Analyzing Risk Saves Time for Monitors
In a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools.
... /Read more/
Regulatory Affairs
Myth vs Fact in Clinical Trial Data Disclosure
The FDA Amendment Act is on its way toward implementation in January 2017. We reveal the facts on clinical trial disclosure for compliance with these new requirements.
... /Read more/
Calendar
/ Clinical Data Disclosure and Transparency 1/18-1/19 /
Philadelphia, Pennsylvania
/ IISR 2017 – Investigator Initiated and Sponsored Research 2/13-2/14 /
Philadelphia, Pennsylvania
/ Meeting the Ethical Standards Under the Clinical Trials Regulation 2/21-2/22 /
Brussels, Belgium
/ Clinical Trial Budgeting & Forecasting /
Philadelphia, Pennsylvania
 
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Lisa Henderson
Editor in Chief
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Mike Tessalone
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