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In this ISSUE

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

Virtual Clinical Trials: The Future of Patient Engagement?

Finally, Standardized KPIs are Front and Center

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Risk Based Monitoring
The Risk Based Monitoring Plan
Sponsors and CROs are looking into implementation of a Risk Based Monitoring approach to their clinical trials to achieve the objectives related to enhanced data quality, better monitoring of patient safety, and creating efficiencies in overall operations.
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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
Patient Centricity
Through the Patient Perspective: Collaborating to Improve Research and Development
At the October Metrics in Patient Centered Drug Development conference hosted by DIA, many of these key constituents gathered to talk about how to implement and measure the impact of patient input.
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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.
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Calendar
/ Partnerships in Clinical Trials Europe 11/28-11/29 /
/ BioPharma Forum on Cannabis-Based Therapies 11/30-12/1 /
/ Clinical Trial Legal and Contracting Forum 12/5-12/6 /
/ eCOA/ePRO 2017 12/13-12/14 /
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Exclusive Interviews from the 2017 DIA Global Annual Meeting
Check out these exclusive interviews from the 2017 DIA Global Annual Meeting in Chicago, IL, conducted by the editors of Pharmaceutical Executive and Applied Clinical Trials. Whether or not you attended the event, here is your chance to gather insights from featured industry professionals.
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Quality Control
Quality Management Systems Demand Continuous Improvement
The biopharmaceutical industry must establish customized approaches to managing Quality Management Systems within their clinical trials processes.
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Beyond #Buzzwords: How to deploy wearables and remote devices to transform your clinical trial execution
Live Webinar: Tuesday, December 5 at 11:00 am EST
Register now
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Navigating the Regulatory Complexities of Orphan Drugs: Know the unwritten rules of designations and what's next
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Lisa Henderson
Editor in Chief
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Trial Management
Community Clinics as Trial Sites—Bridging the Gap Between Health Care and Clinical Research
Turning community clinics into research sites requires provision of personnel, processes, technology, and infrastructure to conduct clinical research.
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Future-proofing your Pharmacovigilance Delivery Model: Achieving scalability and cost effectiveness with AI/smart machines
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CRO Model
Janssen Advances Efficiency and Effectiveness in CRO Oversight Model
Joe Pollarine, Head of GxP Systems Strategy Director at Janssen, recently spoke about CRO oversight models and will expand on these models in this interview.
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Rare Diseases and the Eye - Envisioning Strategies for Success
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Todd Baker
Group Publisher
[email protected]
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