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In this ISSUE

Modeling and Simulation in Clinical Trials: Real Potential or Hype?

FDA Strives to Maintain Gains in Speeding More Breakthroughs to Patients

Preparing Specialty Lab Data for FDA Submission in the New Regulatory Environment

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Protein Biotherapeutic BioAnalysis, by Immunoaffinity LC-MS: Latest Trends and Recommendations
Live Webcast: Tuesday, May 15 at 11:00am EDT
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Clinical Operations
Clinical Trial Quality and Compliance Update
The topic of clinical trial quality and compliance continues to evolve in clinical operations, based on discussions at ExL's 9th Proactive GCP Compliance Conference.
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Operationalizing Gene Therapy Trials
Live Webcasts: Tuesday, May 8, 2018 at 11am EDT | 10am CDT | 4pm BST | 5pm CEST
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Patient Data
Bridging Clinical Research and Clinical Healthcare "Who Owns A Patient's Data?"
Lisa Henderson talks about the topic of "who owns a patient's data" as discussed at the Bridging Clinical and Healthcare Conference 2018.
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Medicine Use and Spending in the U.S. A Review of 2017 and Outlook to 2022
Live Webcasts: Thursday, April 26, 2018 at 10am EDT
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mHealth
Digital Health Lacks Data Dimensionality for Clinical Trials
In this interview, Dr. David Lee Scher adds his perspective on how digital health is changing in both healthcare and clinical trial settings.
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Patient-Centric Complex Trial Design & Site-Less Visits: How Study Design & IRT Can Ease Patient Burdens
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Six Strategies for More Accurate Clinical Trial Forecasting & Budgeting
Live Webcasts: Wednesday, April 25, 2018 at 11am EDT
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Calendar
/ FDA Advisory Committee Master Class 4/26-4/27 /
/ 4th Annual Endpoint Adjudication 5/1-5/2 /
/ Clinical Trial Budgeting and Forecasting 5/2-5/3 /
/ 5th Annual FMV Congress 5/3-5/4 /
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Where Expertise Meets Nuance: Conducting PTSD Clinical Trials
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Move Your Immuno-Oncology Therapy Forward in 2018 and Beyond
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Ask the editor
Lisa Henderson
Editor in Chief
[email protected]
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Todd Baker
Group Publisher
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Scientific Advice with Regulators – An Essential Tool in Early Drug Development
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Data Privacy
How Does GDPR Affect Clinical Trials?
The EU General Data Protection Regulation is the most important change in data privacy regulation in 20 years.
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Managing the Placebo Problem in Chronic Pain Studies
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eConsent Myths
MythBusting: 6 eConsent Myths we Need to Correct in 2018
Debunking the six most common myths regarding electronic informed consent.
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