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In this ISSUE

Real-World Evidence Studies

CTMS: What You Should Know

ICH GCP Goes Risk Based

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Clinical Operations
Overcoming Delays in Europe's Advanced Therapies
As concerns grow about the slow progress of advanced therapies, drug developers are pushing for action from European authorities.
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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.
CRO Outsourcing
The Emergence of the Few: M&A in the CRO Industry
As the size, complexity, duration, cost, and globalization of clinical trials has grown, pharmaceutical and biotech companies have moved to outsource clinical activities to CROs to achieve a wide range of objectives.
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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
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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Navigating the Regulatory Complexities of Orphan Drugs: Know the unwritten rules of designations and what's next
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Biosimilars
Do Biosimilars Require Clinical Trials?
Jill Wechsler talks about biosimilars and the requirement of clinical trials in her recent blog.
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Future-proofing your Pharmacovigilance Delivery Model: Achieving scalability and cost effectiveness with AI/smart machines
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Rare Diseases and the Eye - Envisioning Strategies for Success
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Lisa Henderson
Editor in Chief
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Patient Centricity
Four Pillars to Achieve Patient Centricity
ZS Associates specify the four pillars of patient centricity that can help the demands and complexities of clinical trials.
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Regulatory Authorities, EMA
EMA Relocation Worries Intensify in the Final Stages of the Decision
Tensions mount across the European pharmaceutical scene over the fate of the EMA with just weeks before the final decision is going to be made on where it will be moved to.
... /Read more/
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RBM Technology Impact on Clinical Roles: Centralized Monitoring is streamlining activities and changing roles across clinical development
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Mike Tessalone
Publisher
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